RESEARCH QUESTION What is the effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu for Sukhaprasava. HYPOTHESIS Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu have a significant effect for Sukhaprasava NULL HYPOTHESIS (H0) There is no effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu for Sukhaprasava . ALTERNATIVE HYPOTHESIS (H1) There is significant effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti with Yoni Pichu for Sukhaprasava.
INTRODUCTION: In a woman’s life, motherhood is a crowning act. Every woman tries to enter in this new world of mother with minimum pain, operative aids and complications. As child bearing and delivery are physiological phenomenon and any abnormality in courses of labour can affect women health not only for that time being but also through out her life. That’s why Acharya have given specific importance to the Garbhini and compared her with the pot filled with oil, as slightest oscillation of such pot causes spilling of oil, similarly slightest excitement to the pregnant women can initiate pathological state. Acharya Kashyapa also stated that during Prasava avastha, “Her one foot is in the house of ‘Yama’ (the god of death) and other on this side (i.e., she can die at any moment). Ensuring healthy and safe motherhood with foremost care to every pregnant woman is the outright responsibility of an obstetrician. So, to provide proper attention during pregnancy and delivery the concept of ante natal care as Garbhini paricharya is very explicitly described in ancient literatures which promote easy parturition and healthy progeny. That’s why for good health of mother and baby, Sukhprasava is important. The word Sukhprasava means bringing (or having brought) forth easily or happily. The term ‘prakrit prasav ’ includes: Swabhavh - spontaneous onset Upasthith kala - at term Avaksira - cephalic presentation Swabhawik kal - without undue prolongation So at the onset of labour the foetus gets turned & comes forward due to the action of prasooti marut and then is expelled out through apathyapath this is termed as normal labour.As per Ayurveda the ‘Apaan vayu’ plays an important role along with ‘Vyana vayu’ in act of contraction and relaxation of uterus and in expulsion of foetus. Vyana vayu is essential for contraction & relaxation of myometrium and due to its effect apana vayu becomes active to expel the Garbha outside the garbhashaya. To keep this vayu in balanced state, Acharyas have advised the administration of Asthapana basti, Anuvasan basti, Pichu . Vayu is most likely to be vitiated during pregnancy, and it is described that there is no other remedy more beneficial than administration of ‘Basti’ particularly in affliction of vayu as basti is considered as the paramoushadhi of vata. Need of the Study • The incidence of cesarean section is steadily rising (As per National Family Health survey NFHS the trend of c section deliveries in India has been on rise i.e.21.5 percent in 2019-21) because of increased safety of the operation due to improved anaesthesia, availability of blood transfusion and antibiotics, also its a painless mode of delivery . • Normal delivery is generally preferred over cesarean section because it can lead to a quicker recovery for the mother, reduced risk of infection, and fewer complications. • So to ensure maternal and fetal wellbeing and to bring about normal vaginal delivery and to reduce complications due to C-sections Asthapan basti followed by Anuvasana basti and Yoni pichu can play an important role in normalizing the Apan vayu at the time of child birth and provide a safe passage to the passenger. This study aims to highlight the fact that the principles and formulations regarding striroga and prasuti tantra mentioned in Ayurvedic texts stand invulnerable in this present era and their importance cannot be neglected REVIEW OF LITERATURE: CLASSICAL REVIEW: " In 8th month of pregnancy due to hormonal effect and Kapha Vata prakopa backache, constipation are very common problems. So Acharyas have mentioned Anuvasan and Aasthapan Basti in 8th month in Garbhini paricharya containing drugs mainly Kapha and Vata shamak. This Basti regulates Vata and clear the retained feces. Due to movement of vayu in its right direction, it delivers the baby without difficulty and remains free from complications. According to Sushruta - Aasthapan Basti:3 Decoction of badar is mixed with bala, atibala, shatpushpa, palala, milk, curd, oil, salt, madanphala, honey and ghrita. Anuvasan Basti: Oil medicated with milk and decoction of madhur group drugs are mentioned in Anuvasan Basti. Yonipichu (vaginal tampon): Yonipichu is the application of sterile swab soaked in medicated oil or decoction into the vagina.
DRUG REVIEW | Sr no | Latin name | Rasa | Guna | Virya | Vipaka | Karma | Parts used | Quantity | | Badar | Zizyphus jujube Lamk. | Amla, madhur,kashaya | Snigdha, guru, | sheet | Madhur | vata pitta nashakVatanulomana, malabhedana | Fal majja | 200g | | Shatpushpa | Anethum sowa Kurz | Umbelliferae | Katu, ushna, laghu, ruksha, tikshna | Ushna | Madhur | Vatanulomana, vedanasthapana | Seeds | 10g | | Bala | Sida cordifolia Linn | Malvaceae | Snigdha,Guru,Picchila | sheet | Madhur | Balya, vryshya, vatapitta hara, | Roots | 10g | | Atibala | Abutilon indicum Linn | Malvaceae | Guru,Snigdha,Picchila | Sheet | Madhur | Vatahara, beej snehana, mruduvirechaka, vedanahara, balya | Roots | 10g | | dugdha | milk | madhur | Mrudu ,snigdha ,guru | sheet | madhur | Balya ,ojavridhhi | | 16ml | | Palal | | | | | | | | 16ml | | Ghrit | | madhur | | sheet | madhur | Agni,virya,oja vardhak,vatapittashamak | | 16ml | | Dadhi | curd | Madhur ,amla,kashaya | Snigdha,guru | ushna | amla | Snehan,vatanashak,balvardhak | | 16ml | | Mastu | Liquid part of curd | Amla ,kashaya madhur | Laghu,rukshya | sheet | | Vatakaphashamak,srotovishodhaka | | 16ml | | taila | Sesame oil | Madhur,kashaya | Sukshma,vyavayi, | Ushna | | Vatanashak,balya | | 80ml | | Lavan | Salt | Madhur | Sukshma ,laghu | Sheet | Madhur | Tridoshnahak | | 5g | | Madanphala | Randia spinosa | Kashaya,katu,tikta,madhur | Laghu ,ruksha | Ushna | Katu | Kaphavatahara | Seeds | 10g | | Madhu | honey | Kashaya,madhur | Guru,sheet,ruksha | Sheet | Madhur | Kaphanashak,chhedak | | 80g | Ingredients of madhuraushadh siddha tail - | No | Drug | Latin name | Family | Proportion | Part used | | 1 | Guduchi | Tinospora cordifolia( Willed.Miers) | Meninspermaceae | 1 part | Stem | | 2 | Ashwagandha | Withania somnifera Dunal | Solanaceae | 1part | Root | | 3 | bala | Sida cordifolia Linn | Malvaceae | 1part | Root | | 4 | Atibala | Abutilon indicum Linn | Malvaceae | 1part | Root | | 5 | Yashtimadhu | Glycerrhiza glabra Linn | Leguminoceae | 1part | Root | | 6 | Tilataila | Sesamum indicum | pedaliaceae | 16 parts | - | | No | Drug | rasa | guna | virya | vipaka | Karya | | 1 | Guduchi | Kashaya ,tikta | Laghu ,snigdha | Ushna | Madhur | Tridoshhara ,balya | | 2 | Ashwagandha | Madhur | Guru, snigdha | Ushna | Madhur | Balya | | 3 | Bala | Madhur | Guru ,snigdha,pichhil | Sheet | Madhur | Vatapittashamak ,antiinflamatory | | 4 | Yashtimadhu | Madhur | Guru ,snigdha | Sheet | Madhur | Vatashaman ,antiinflamatory | | 5 | Tiltaila | Madhur ,kashaya | Sukshma ,vyavayi | Ushna | | Vatanashaka ,balya | | 6 | Atibala | Madhura | Laghu ,snigdha | Sheet | Madhur | Balya ,brihan,vatapittashaman | MODERN REVIEW NORMAL LABOUR : Series of events that take place in the genital organs in an effort to expel the viable products of conception (fetus, placenta and the membranes) out of the womb through the vagina into the outer world is called Labor. It may occur prior to 37 completed weeks, when it is called the preterm labor. CRITERIA OF NORMAL LABOR (EUTOCIA): Labor is called normal if it fulfills the following criterias. (1) Spontaneous in onset and at term. (2) With vertex presentation. (3) Without undue prolongation. (4) Natural termination with minimal aids. (5) Without having any complications affecting the health of the mother and/or the baby. CAUSES OF ONSET OF LABOR The precise mechanism of initiation of human labor is still obscure. Endocrine, biochemical and mechanical stretch pathways as obtained from animal experiments, however, put forth the following hypotheses. 1.Uterine distension: Stretching effect on the myometrium by the growing fetus and liquor amnii can explain the onset of labor at least in twins or polyhydramnios. 2. Fetoplacental contribution: Cascade of events activate fetal hypothalamic-pituitary-adrenal axis prior to onset of labor �’ increased CRH �’ increased release of ACTH �’ fetal adrenals �’ increased cortisol secretion �’ accelerated production of estrogen and prostaglandins from the placenta. 3. Estrogen: Increases the release of oxytocin from maternal pituitary. — Promotes the synthesis of myometrial receptors for oxytocin and prostaglandins. — Increases the excitability of the myometrial cell membranes. 4. Progesterone: Cortisol inhibits the conversion of fetal pregnenolone to progesterone. Progesterone levels therefore fall before labor. It is the alteration in the estrogen : progesterone ratio. 5.Prostaglandins: Prostaglandins are the important factors, which initiate and maintain labor. The major sites of synthesis of prostaglandins are—amnion, chorion, decidual cells and myometrium.Synthesis is triggered by—rise in estrogen level,glucocorticoids, mechanical stretching in late pregnancy, increase in cytokines (IL–1, 6, TNF),infection, vaginal examination, and separation or rupture of the membranes. 6. Oxytocin and myometrial oxytocin receptors: (i) Large number of oxytocin receptors are present in the fundus compared to the lower segment and the cervix. (ii) Receptor number and senitivity increases during pregnancy reaching maximum during labor. (iii) Oxytocin stimulate synthesis and release of PGs (E2 and F2α) from amnion and decidua. Vaginal examination and amniotomy cause rise in maternal plasma oxytocin level (Ferguson reflex). Fetal plasma oxytocin level is found increased during spontaneous labor compared to that of mother. Its role in human labor is not yet established. STAGES OF LABOR - Conventionally, events of labor are divided into three stages: 1.First stage: It starts from the onset of true labor pain and ends with full dilatation of the cervix. It is, in other words, the “cervical stage†of labor. Its average duration is 12 hours in primigravidae and 6 hours in multiparae. 2.Second stage: It starts from the full dilatation of the cervix (not from the rupture of the membranes) and ends with expulsion of the fetus from the birth canal. It has got two phases— 3.Third stage: It begins after expulsion of the fetus and ends with expulsion of the placenta and membranes(afterbirths). Its average duration is about 15 minutes in both primigravidae and multiparae. 4.Fourth stage: It is the stage of observation for at least1 hour after expulsion of the afterbirths. During thisperiod maternal vitals, uterine retraction and any vaginal bleeding are monitored. Baby is examined. MECHANISM OF NORMAL LABOR DEFINITION: The series of movements that occur on the head in the process of adaptation during its journey through the pelvis is called mechanism of labor. MECHANISM: In normal labor, the principal movements are: (1) engagement, (2) descent, (3) flexion, (4) internal rotation, (5) crowning, (6) extension, (7) restitution, (8) external rotation, and (9) expulsion of the trunk. PREVIOUS WORK DONE | S No | Institution | Author | Year | Title | | 1 | Deptt.of Prasuti and Stri Roga Veena Vadini Ayurvedic College Bhopal | Meenakshi pal | 2016 | Role of anuvasanvasti with pichu & sukh prasavkar yoga in pregnancy on progress of labour | | 2 | ASS College Nashik | Jadhav Archana | 2017 | Study of efficacy of bala siddha taila pitchu on cervical ripening and effacement | | 3 | Department of P.T.S.R, J.G.Cop. Society Ayurvedic medical college, Ghataprabha. | Dr Verma Neha | 2018 | Role of kadamba masha taila anuvasana vasti in the ninth month of pregnancy for sukhaprasava | | 4 | National Institute of Ayurveda ,Jaipur | Dr Priyanka Hajare | 2020 | Sukhaprasava (Normal labour) in ancient literature:A review | | 5 | Lecturer shri Jayendra Sarswati Ayurveda college Nazaraphet Chennai and former professor head of prasuti tantra and dean of IMS BHU Varanasi | K.Prameela devi and P.V.Tiwari | 2005 | Comparative study of Baladi taila and Tila taila pichu in the management of Prasava | | 6 | Bidar | Baswade J et al | 2011 | Matra basti with Yoni pichu with Bala tail | | 7 | Hadapsar | Gawade T. et al | 2015 | Anuvasan basti with Balasidhha tail | | 8 | RGGPGAC Paprola HP | Chandla Anubha et al | 2015 | Matra basti with yoni pichu with Balyam tail | OUTCOME OF THE CITED STUDIES : All the previous trials reported a positive outcome of the Anuvasana basti /or Yoni pichu/Asthapana basti in ninth month or during labour .It promotes normal vaginal delivery with reduction in duration of labour lesser need of induction and augmentation of labour .bishops score was more favourable in patients where vaginal tampon of medicated oil was given. OBJECTIVES: The present research trial has been undertaken with the following objectives PRIMARY OBJECTIVES: 1. Assessment of effect of Badarodakadi Asthapana Basti followed by Madhuraushadhi Siddha Tail Anuvasana Basti and Yoni Pichu on Sukhaprasava through bishop’s score. SECONDARY OBJECTIVES 1. Assessment of effect of the given intervention on APGAR Score of the baby. . METHODOLOGY | STUDY DESIGN | Clinical Trial | | STUDY SITE | Opd ipd of AIIA | | MASKING | Open label | | RESEARCH DESIGN | Interventional study | | SAMPLE SIZE | 87 | | GROUP | One | | | | screeniscngs enennkhdgdijrollmenthh Baseline evaluation (ANC profile) | Administration of Badarokadi Asthapana Basti followed by Madhuraushadhi Sidhha Tail Anuvasana Basti and Yoni Pichu | Data analysis on interpretation | PATIENT SETTING Patients will be selected from the O.P.D and I.P.D of the Prasuti tantra and Striroga department, All India Institute of Ayurveda, New Delhi, irrespective of occupation and religion. Patients will be selected strictly as per the inclusion criteria given in the Proforma specially designed for the study and recruited into trial after obtaining voluntary consent. SAMPLE SIZE: Proposed study is to assess the effect of Badarodakadi asthapana basti with madhuraushadhi siddha anuvasan basti with pichu .Study aims to promote the occurence of normal vaginal delivery.As per data available in earlier studies , Bishops score was found to be favourable in 78% of cases,assuming it to be 90% in this study with 80% power, 5% level of significance and two sided test, the calculated sample size is 79 in one group .Assuming 10% drop outs, we will take 87 cases in the study. SELECTION OF PATIENTS A written and informed consent will be taken from the patient before the commencement of the treatment. The study will be conducted on Pregnant females fulfilling all the inclusion & exclusion criteria visiting P.G. Department of Prasuti and Striroga of All India Institute Of Ayurveda ,New delhi. CRITERIA FOR SELECTION OF PATIENTS Inclusion criteria · Primigravida of 36-38 weeks of age group between 20-35 years. · Normal fetal presentation at term. · Normal pelvic measurement (adequate pelvis). · Patients willing to give written informed consent · ICD-10-CM DIGNOSIS CODE O80 Encounter for full-term uncomplicated delivery. Exclusion criteria · Patients having cepholopelvic disproportion, malpresentation, abnormal size of foetus, contracted pelvis. · Patients having systemic diseases like tuberculosis, jaundice, heart diseases, epilepsy etc. · Patients having polyhdraminos, pre-eclamsia, eclampsia, and IUGR. · Multiple pregnancies. · Malignancy of genital tract. · Pelvic masses causing obstruction & vaginal obstruction (adhesion & stenosis) · Pregnant women who are unsuitable for basti treatment ( basti ayogya ) INVESTIGATIONS: Following investigations will be carried out at All India Institute of Ayurveda,Delhi Routine Investigations :- • Hemogram, Blood Group, RBS, Urine- Routine and Microscopy, Viral Markers, Thyroid Profile, S.Urea, S. Creatinine, LFT, RFT, CRP , Coagulation profile. • USG (Trimester Wise) Other investigations :- ECG, 2D Echo will be advised in suspected cases to rule out other specific diseases . DRUG PROCUREMENT SOURCE OF DRUG COLLECTION: Raw drug will be procured from authentic sources. Identification and quality standardization will be done. Method of preparation Asthapan basti - will be prepared as per the classical reference given in the charak samhita. Madhuraushadh sidhha tail : In this study 5 drugs guduchi, ashwagandha yashtimadhu bala atibala are selected from Madhura Skandha of Vimana-Sthana-8. These drugs are selected due to their easy availability & expected high degree of clinical effects. For Moorchhana of Tila Taila reference will be taken from Bhasajyaratnavali-Jwararogadhikar Adhayay. After Moorchhana of TilaTaila, Madhura Aushadha Sidhha Taila will be prepared with Taila Paka Vidhi by adding these drugs to Moorchhita Tila Taila. The Taila will be prepared in pharmacy of All India Institute of Ayurveda New Delhi. QUALITY CONTROL AND STANDARDIZATION PARAMETERS FOR MADHURAUSHADH SIDHHA TAIL : | Sr .no. | Tests | | 1. | Description Colour Odour | | 2. | Weight /ml | | 3. | Refractive indx at 25 c | | 4. | Viscocity | | 5. | Iodine value | | 6. | Saponification value | | 7. | Acid value | | 8. | Peroxide value | | 9. | Identifications GLC/TLC/HPTLC-with marker wherever available | | 10. | Test for heavy metals Lead,cadmium, mercury,arsenic | | 11. | Microbial contamination Total bacterial count Total fungal count | | 12. | Test for specific pathogen e.coli, Salmonella spp.,S.aureus,Pseudomonas aeruginosa | | 13. | Pesticide residue Organochlorine pesticides Organophosphorus pesticides Pyrethroids | | 14. | Test for Aflatoxins (B1,B2,G1,G2) | INTERVENTION CHART | | NAME OF THE DRUG | MODE OF APPLICATION | DOSE | DURATION | | | Asthapan basti with badarodak kashaya | Anal route | 480ml | 1day ( 1st day of 36th week ) | | | Madhuraushadh sidhha tail anuvasan basti Madhuraushadh sidhha tail pichu | Anal route Vaginal route | 60ml | 7days ( will be started from 2nd day of Asthapana basti ) 7days ( will be given just after the Anuvasana basti | " SOP of " Aasthapan basti BASTI (MEDICATED ENEMA) Bastikarma is the procedure by which the medicines in suspension form are dministered through rectum or genitourinary tract using bastiyantra.It is the most appropriate remedial procedure for vatadosha. Poorvakarma 1. Probable benefits and risks of procedure will be explained to patient. 2. Patients will be advised to get relieved of their urges of defecation and micturition 3. Anal region will be cleaned with a cotton piece soaked in plain lukewarm water Pradhankarma : The patient is asked to lie on left side drawing up the right leg and straightening of the left leg. 1. Apply little quantity of oil on patient’s anus and nozzle of bastiyantra. 2. The nozzle is gently inserted into the anal canal upto a specific length and bastiputak containing mixture is pressed with uniform pressure.The pressure is continued till only small quantity of fluid remains in the bag. 3. Then the nozzle is removed gently and the patient is allowed to lie down in supine position till he fills urge to excrete. 4. The basti dravya along with faeces normally comes out within 10 minutes when a full dose of Niruha basti is given. The maximum time specified for retention of bastidravya is 48 minutes. After evacuation of the bowel, the patient may take hot water bath and semi solid diet. Usually Niruha bastis are not to be given alone. Wherever required, Niruha basti must be given alternatively with Snehabasti. 2. SNEHA BASTI (OIL ENEMA): Administration of medicated oil through anal route is called sneh basti.The dosage from anal route may vary from 60ml to 240ml according to doshika predominance,disease condition/patient’s condition. Procedure: Sneha is administered in similar manner as niruha basti.As it is a retension enema,the contents should be allowed to retain inside for a minimum period of three hours . . Pashchatkarma : After the drug has been injected, the waist and foot end should be raised to lift the trunk, in order to facilitate withholding of the drug as long as possible,the buttocks should be patted for maximum retention. Finally, the patient is directed to discharge his urges in Utkataasana (squatting position). Dose: · The dose is to be manipulated according to the contemporary period · Niruha Basti: 480 ml/Basti · Anuvasana Basti:. 60ml /Basti Kala: · Niruha Basti should always be given empty stomach or when the previous food has been digested but the appetite is not evoked. · Anuvasana Basti on the contrary, should never be administered before meals. Pratyagaman kala: The time period in which the Basti Dravyas return back is Pratyagaman Kala. The maximum Pratyagamana Kala for Niruha Basti has been assigned as one Muhurta (app. 48 mins.) For Anuvasana Basti, however, the maximum time limit is three Yaam (12 hrs). For Niruha Basti, if Pratyagama doesn’t occur then Phalavarti or Tikshna Basti may be introduced. Yoni pichu: All procedures to be done under all aseptic precautions.duration of procedure 7days minimum. Equipments required: autoclaved pichu,sterile gloves,sterile cotton swabs. Procedure : 1. ask the patient in supine position with knees flexed. 2. Clean vulva and vagina with antiseptic solution. 3. Sterile pichu soaked in medicated ghee/oil should be taken and has to be inserted in vaginal canal with tail lying outside vagina. 4. Guide patient to take out the pichu after 2 hrs or until urge of urination. Assessment Criteria- The clinical result will be assessed by observing whether the pregnant woman will have Sukha and Nirupadrava Prasava or not and for that the following parameters will be adopted. - Bishop’s Score
- Labour progress according to Partogram
- Total duration of labour
- Duration and frequency of uterine contractions
- Fetal weight by USG
- Mode of delivery
- Onset of labour
§ Induction/Augmentation required or not required A.Grade-0 Onset of Labour - Spontaneous Partogram - Before Alert Line Uterine Contractions - Normal Pattern Type of Delivery - Spontaneous Vaginal Delivery without Episiotomy Grade-I Onset of Labour - Spontaneous Partogram - Before Alert Line/ Between Alert Line &Action Line Uterine Contractions - Normal Pattern Type of Delivery - Spontaneous Vaginal Delivery with Episiotomy or with perineal tear Grade-II Onset of Labour - Induced Partogram - Before Alert Line between Alert Line &Action Line Uterine Contractions - Normal Pattern/Irregular Pattern Type of Delivery - Spontaneous Vaginal Delivery with or without Episiotomy. Grade-III Onset of Labour - Spontaneous/Induced Partogram - After Alert Line Uterine Contractions - Irregular Pattern Type of Delivery - L.S.C.S. B. Duration of Uterine contraction : 0 = > 60 Seconds 1 = 46 – 60 seconds 2 = 31 – 45 Seconds 3 = < 30 Seconds Frequency Of uterine Contraction : 0 = 4 contractions /10 Minutes 1 = 3 contractions /10 Minutes 2 = 2 Contractions /10 Minutes 3 = 1 Contraction /10 Minutes C. Bishop’s Score : 0 = 10 – 13 Score 1 = 7 – 9 Score 2 = 4 – 6 Score 3 = 1 – 3 Score BISHOP’S MODIFIED SCORING: Each components is given a score of 0-2 or 0-3. The highest possible score is 13. | | 0 | 1 | 2 | 3 | | Cervical Dilatation(cm) | Closed | 1-2 | 3-4 | 5+ | | Cervical Length(cm) | >4 | 3-4 | 1-2 | <1 | | Cervical Consistency | Firm | Medium | Soft | - | | Cervical Position | Posterior | Midline | Anterior | - | | Head station | -3 | -2 | -1,0 | +1,+2 | | indicator | | O points | 1 point | 2 points | | A | Activity ( muscle tone) | Abesnt | Flexed limbs | Active | | P | Pulse | Absent | <100 bpm | >100bpm | | G | Grimace (reflex irritability) | Floppy | Minimal response to stimulation | Prompt response to stimulation | | A | Appearance | Blue pale | Pink body blue extremeties | Pink | | R | Respiration | Absent | Slow and irregular | Vigorous cry | A - severely depressed 0-3 B - moderately depressed 4-6 C- excellent condition 7-10 Pain threshold during labour: Score | Severe labour pain (Poor pain threshold) 3 | | Moderate 2 | | Mild (Good) 1 | Bearing down efforts: (Pravahana) | Very good effort 3 | | Good effort 2 | | Poor effort 1 | After Pains : | Severe Pain 3 | | Moderate pain 2 | | Mild pain 1 | | No pain 0 | Post partum bleeding: | Severe bleeding (more than 500 ml) 3 | | Moderate bleeding (351 - 500 ml) 2 | | Mild bleeding (201 - 350ml) 1 | | Normal bleeding (l00 - 200 ml) 0 | WITHDRAWAL CRITERIA · If there is any complication. · If the condition of the patient deteriorates during the trial. · Patient not willing to continue in the study or incompliance for 3 or more than that days . RESCUE MEDICATION & ADR If there is any occasion of adverse effect, additional pharmacological drugs will be prescribed in consultation with the contemporary medical practitioners or other ayurvedic drugs will be administered in consultation with the experts in the field. If Any adverse drug reaction observed By Doctor or Patient it will be recorded and reported to Pharmacovigilance center, AIIA,New Delhi. ETHICS COMMITTEE CLEARENCE: Study will be started after getting clearance from Institutional Ethics Committee., and after CTRI Registration Reporting of ADR (Adverse Drug Reaction), if any observed by doctor/patient will be reported to the specific authority. Pharmacovigilance center, AIIA,New Dlhi STUDY MONITORING: The study will be monitored at Department of Striroga evam Prasuti Tantra,All India Institute by Guide, Co-guides and faculties of the department. PATIENT COMPLIANCE PROTOCOL : · Participants will be provided with a compliance chart which they will be required to fill every day. · Participants will be monitored on regular basis through call/whatsapp. · Minimum 80% compliance is must to continue the study. · Treatment plan,its importance,potential side effects,expected outcomes will be explained to the participants in the way they can understand. CONFIDENTIALITY: · The information that we collect from the study project will be kept confidential. · Information on your health and mental status(as the case may be) that will be collected while conducting the research will be kept confidential and no one but the researchers will be able to find it also all the information about the participant will be coded. · Only the All India Institute of Ayurveda Ethics Committee and other regulatory bodies under Government of India law would have access to these records. TRANSLATIONAL VALUE O F THE RESEARCH : • Present study could help validate and promote the use of this traditional medical practice like basti and vaginal tampon in modern obstetrics • It could reduce the occurrence of surgical complications in childbirth which might have broader implications for maternal and infant health .This could translate into shorter labor duration ,potential to reduce healthcare costs CO-OPERATION REQUIRED: • Identification of the raw drug from Department of Dravyaguna • Pathology Lab, AIIA Hospital • Library, AIIA Hospital • Pharmacy, AIIA Hospital • Preparation of medicines from the department of rasa shastra AIIA •OPD &IPD, AIIA Hospital If needed help will be taken from other departments of AIIA with due permission from concern authority during the course of study. STUDY ENDPOINTS: PRIMARY 1.Improvement in BISHOP score ( > 8) SECONDARY 1.Improvement in APGAR Score. · Outcomes will be assessed by the BISHOP score and APGAR Score tables given in the assessment criteria. · Bishop score of 8 or greater is considered to be favorable for induction, or the chance of a vaginal delivery with induction is similar to spontaneous labor. A score of 6 or less is considered to be unfavorable if an induction is indicated cervical ripening agents may be utilized.The most common modification to the Bishop score is a simplified scoring system that just takes into account dilation, effacement, and station (each scored 0 to 3 points). In this shortened modification, a score of more than 5 is considered favorable. · If APGAR score is 0-3 baby will be considered as severely depressed,4-6 as moderately depressed and 7-10 as excellent condition . FINANCIAL SUPPORT: This study will be completed within the prescribed financial limit for the work. However, if more finance is required, the request will be made for due permission and approval of extra budget to the concerned authority AIIA, in due course of research work. | No | TASK | COST | | 1. | Investigations | 20,000 | | 2. | Medicines | 60,000 Total – 80,000 | GANTT CHART: | ACTIVITIES | June 2023 | July 2023-Sept 2013 | Sept 2023- Oct 2023 | Oct 2023 | Nov23-Jan 2024 | February 2024 | April 2024-May 2025 | June 2025-aug 25 | Sep - Oct 2023 | | · Selection research Problem | of | | | | | | | | | | | | · Review literature | of | | | | | | | | | | | | · Preparation Synopsis | of | | | | | | | | | | | | · Submission Synopsis | of | | | | | | | | | | | | · Presentation synopsis | of | | | | | | | | | | | | · Re-Evaluation of synopsis after IRB suggestions | | | | | | | | | | | | · Resubmission of synopsis | | | | | | | | | | | | · Preparation of patient consent form, patient information sheet, case record forms | | | | | | | | | | | | · IEC clearance | | | | | | | | | | | | · Procurement and preparation of trial drugs | | | | | | | | | | | | · Recruitment subjects | of | | | | | | | | | | | | · Commencement of trial | | | | | | | | | | | | · Data analysis | | | | | | | | | | | | · Submission thesis | of | | | | | | | | | | | LIST OF REFERENCES 1.Prof.Siddhi Nandan Mishra. Bhaisajya Ratnavali by Kaviraj Govindnath Sen Siddiprada , Hindi commentary, Garbhinirogadhikar 68/57. Reprint 2011. Varanasi: Chaukambha Surbharti Prakashan; 2011.p. 1057. 2.Prof.Siddhi Nandan Mishra. Bhaisajya Ratnavali by Kaviraj Govindnath Sen Siddiprada, Hindi commentary, Jwarrogadhikar 5/1268. Reprint Varanasi: Chaukambha Surbharti Prakashan: 2011.P.206. 3.Prof.Siddhi Nandan Mishra. Bhaisajya Ratnavali by Kaviraj Govindnath Sen Siddiprada, Hindi commentary, Garbhinirogadhikar 68/57.. Reprint 2011 Varanasi: Chaukambha Surbharti Prakashan; 2011;p.1057. 4.D.C Dutta, Text Book Of Obstetrics Including Perinatology And Contraception, Edited By Hiralal Konar. 7th Edition. Reprint 2011.New Central Book Agency: Londo; 2011.p.131. 5.Dr.Ravi Dutta Tripathi. Ashtang sangraha Saroj,, Hindi Commentary Sutrasthan 1/48 .Reprint 2001. Varanasi; Chukambha Prakashan, 20. 6.Bhavprakash Nighantu, Indian Materia Medica. Bhavmishra, Bharati Acadamy, Varanasi , 10th edi, 1995 7.Kashinath Pandey And Gorakhnath Chaturvedi . Charak samhita Vidyotini vyakhya Part –I,. Shareer Sthan 6/24, Reprint 2009. Varanasi: Chaukambha Bharti Academy: 906. 8.Sushrutsamhita with Ayurveda TatvaSandipika Hindi commentary, KavirajAmbikaDuttaShastri Part-1, Reprint 2008. Chaukhamba Sanskrit SansthanSharirSthan,Garbhinivyakararan sharir adhyaya 10/5 9.Vaidya Vijay Shankar Kale. Charak samhita with Vaidyamanorama hindi commentary,Vimansthana rogbhishagjitiya adhyaya 8 ,shloka no 139. 10. Vaidya Vijay Shankar Kale. Charak samhita with Vaidyamanorama hindi commentary,Sharirsthan jatisutriya shariradhyaya 8/31/4 11. Vaidya Vijay Shankar Kale .Charak samhita with Vaidyamanorama hindi commentary,Sharirsthan Sharirvichaya sharirad. 12.Meenakshi Pal, Sushila aSharma and B. Pushpalatha ROLE OF ANUVASANA BASTI WITH PICHU AND SUKHAPRASAVAKARA YOGA ON PROGRESS OF LABOUR, World Journal of Phrarmaceutical Research,5(4),852-866 13.Jadhav Archana S ,Ghorpade Manda ,Study of efficacy of bala sidhha taila pichu on cervical ripening and effacement,International Journal of Reseach in Indian Medicine,1(3),2017 14.Dr Verma Neha,Dr Bagali C.S,Role of Kadamba Mash Tail Anuvasana Vasti In The Ninth Month of Pregnancy For Sukhaprasava,PIJAR,3(2),2018. 15K.Prameela Devi and P.V. Tiwari,COMPARATIVE STUDY OF BALADI TAIL AND TILA TAILA PICHU IN THE MANAGEMENT OF PRASAVA,J.R.A.S.3(4),2009
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