| CTRI Number |
CTRI/2020/01/022935 [Registered on: 24/01/2020] Trial Registered Prospectively |
| Last Modified On: |
29/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
usage and benefits of Ayurveda medicines SOUBHAGYA SHUNTHI PAKA AND DASHAMULARISTA IN sutika (after delivery(Post natal period) |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF THE EFFICACY OF SOUBHAGYA SHUNTHI PAKA AND DASAMOOLARISTA IN SUTIKA PARICHARYA (POST NATAL CARE) |
| Trial Acronym |
SPDA IN PNC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKPrameeladevi |
| Designation |
Research Officer (Ay) Scientist-3 |
| Affiliation |
Dr.Achanta Lakshmipathi Research Centre for ayurveda,CCRAS,M/o of AYUSh,Govt.of India |
| Address |
Research Officer (Ay) Scientist-3 Dr.Achanta Lakshmipathi Research Centre for ayurveda, VHS Campus Hospital Taramani,Chennai
Chennai TAMIL NADU 600113 India |
| Phone |
9445812604 |
| Fax |
|
| Email |
kprameel@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrKPrameeladevi |
| Designation |
Research Officer (Ay) Scientist-3 |
| Affiliation |
Dr.Achanta Lakshmipathi Research Centre for ayurveda,CCRAS,M/o of AYUSh,Govt.of India |
| Address |
Research Officer (Ay) Scientist-3 Dr.Achanta Lakshmipathi Research Centre for ayurveda, VHS Campus Hospital Taramani,Chennai Chennai TAMIL NADU 600113 India |
| Phone |
9445812604 |
| Fax |
|
| Email |
kprameel@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrKPrameeladevi |
| Designation |
Research Officer (Ay) Scientist-3 |
| Affiliation |
Dr.Achanta Lakshmipathi Research Centre for ayurveda,CCRAS,M/o of AYUSh,Govt.of India |
| Address |
Research Officer (Ay) Scientist-3 Dr.Achanta Lakshmipathi Research Centre for ayurveda, VHS Campus Hospital Taramani,Chennai
Chennai TAMIL NADU 600113 India |
| Phone |
9445812604 |
| Fax |
|
| Email |
kprameel@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES MINISTRY OF AYUSH GOVT OF INDIA |
|
|
Primary Sponsor
|
| Name |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India, JawaharLal Nehru BhartiyaChikitsaEvam Homoeopathy AnusandhanBhawan, 61- 65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058, INDIA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KPrameeladevi |
Dr Achanta Lakshmipathi Research centre for ayurveda |
Dr Achanta Lakshmipathi Research centre for ayurveda VHS CAMPUS HOSPITAL CHENNAI Chennai TAMIL NADU |
9445812604
kprameel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL EHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
to see the efficacy of Ayurvedic Drug interventions in postnatal mothers in increasesd quantity of milk involution of uterus pain abdomen |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Primipara / Multipara with non-complicated full term vaginal delivery,
2. Age between 20 – 35 years
3. Woman willing and able to participate in the study.
4. Woman in 3rdto 10thpostnatal day.
|
|
| ExclusionCriteria |
| Details |
1. Woman who delivered by Caesarian section or forceps delivery/ vacuum application
2. Woman after 11thpostnatal day.
3. Puerperium associated with complications like severe postpartum haemorrhage, acute inversion of uterus, puerperal eclampsia, psychosis, postnatal gestational Diabetes
4. With uncontrolled hypertension (>160/100 mm of Hg).
5. With uncontrolled diabetes mellitus {HbA1c> 8.0 %.)
6. With evidence of malignancy.
6. Mothers with active herpes breast/breast abscess/retracted nipple/severely cracked nipples, having h/o of HbsAg+ve, HIV+ve, Tuberculosis, Chronic medical conditions.
7. Any other condition which the Principal Investigator thinks may jeopardize the study.
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical efficacy of Soubhagya Shunthi Paka and Dasamoolarishta in SutikaParicharya (w.s.r to postnatal care) |
To assess the clinical efficacy of Soubhagya Shunthi Paka and Dashamularista in SutikaParicharya (w.s.r to postnatal care) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the clinical efficacy of Soubhagya Shunthi Paka and Dashamularista in SutikaParicharya (w.s.r to postnatal care)
Improvement in Quality of life by the sustainable effect of Soubhagya Shunthi Paka and Dashamularista. |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/11/2021 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A postnatal period begins immediately after the separation of placenta and extending up to six weeks (this period varies as some Acharyas described up to 45days or up to 6 months after delivery)1, otherwise called as puerperium or puerperal period. The care given during this period is called as SutikaParicharya in Ayurveda. During the time of labour mother undergoes tremendous physical exertion and becomes extremely debilitated physically and mentally; which leads to derangement of Doshas especially Vatadosha in the mother. These pathological changes cause general weakness, pain abdomen, low back pain, loss of appetite, dysfunction of bladder, post-natal psychosis etc. Apart from these, mother also suffers with Dhatukshya. If this stage is unattended by appropriate measures then that will lead to maternal morbidity. In order to reduce the postpartum maternal morbidity, reforming postpartum care measures by providing holistic and flexible maternal health care is necessary. The WHO suggested that maternal care should be de-medicalized, individualized, family-centered, multidisciplinary, holistic, and culturally appropriated. In the existing modern medical system, puerperal care limits to supplementation of the iron, calcium and prevention of infections. Two major demands of Puerperium i.e. care for proper involution of genital organs and ensuring optimum lactation are still left un-addressed. Whereas in Ayurveda medicaments and procedures described for post-natal woman is culturally very much appropriate, is by and large comprehensive in serving all the demands of the pueperium. It is by far more scientific and helps in proper involution of the uterus, ensures optimum lactation, kindles digestive as well as metabolic fire, replenishes the lost Dhatu (tissue elements), prevents infections, helps to regain tone of urinary bladder and other smooth muscle 22 organs like intestines, finally it ensures the uneventfullpueperium and complete growth of the baby. Importance of This Work: In the modern system of medicine supplementation of heamateanics, Calcium and Vitamins are available for the management of Sutika Kala (post-natal phase). These medicines will take care of replenishment of mineral and vitamins only. However the other demands of post-natal phase like strengthen of uterus and urinary bladder, adequate quantity of breast milk and also improvement appetite as well as general well being are not full filled with these treatments. These Ayurvedic formulations (SoubhagyaShunthiPaka and Dashamularista) has been in use since ages, and has been found to be useful in treating Sutika (post-natal women) and promoting the health. The present study is being undertaken to scientifically study and validate the effect of this Ayurvedic formulation. Drug Review In the present study two popular and classical prescription of Ayurveda are taken up for validation namely Dashamularishta and SoubhagyaShunthiPaka. 1. SoubhagyaShunthiPaka (AFI-I, Vol-I, Page No-160-162) This formulation is prescribed in Ayurvedic classics in the management of Sutika (Pueperal woman) and is also used by folks in different parts of Indian subcontinent. This formulation is very appropriate in catering the demands of the post natal phase like involution of uterine, achievement of optimum lactation, regaining of tone of urinary bladder, intestines etc. This drug is mentioned in Ayurvedic formulary of India, Volume-I, page number 160-162. 2. Dashamularista (AFI-I, vol-I, Page No-13-14; API-part-II, vol-II, Page No20-24) Dashamularishta is the first line compound drug used in the management of Vata predominant disorders. Sutika phase is predominant of Vata; it gets aggravated during labour and same aggravation continues in the post natal phase also due to Dhatukshaya (tissue destruction and loss). Hence in the present study Dashamularishta is taken up for validation. Some studies are also carried out with this drug in Post natal care. This preparation is standardized and also mentioned in Ayurvedic Formulary of India-I, in volume-I, Page No-13-14; API-part-II, Vol-II, Page No20-24. 23 Co-ordinating Centre: |