CTRI/2024/04/065704 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On:
10/04/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Research on Infertility through Uttar Basti
Scientific Title of Study
A Randomised control trial to evaluate the efficacy between Lasuna Taila
Uttar Basti and Apamargakshara Taila Uttar Basti in the Management of
Bandhyatwa (Tubal Blockage Infertility)
Trial Acronym
bandhatwa
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Amrita Thapa
Designation
PG scholar
Affiliation
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar
Address
Room no.123 PG Department of Panchakarma Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar,Delhi
South West DELHI 110073 India
Phone
8178834203
Fax
Email
amritashah09@gmail.com
Details of Contact Person Scientific Query
Name
ProfDr Arun Gupta
Designation
HOD Panchakarma
Affiliation
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar
Address
Room no.142 PG Department of Panchakarma Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar
South West DELHI 110073 India
Phone
8178361290
Fax
Email
arun24@hotmail.com
Details of Contact Person Public Query
Name
ProfDr Arun Gupta
Designation
HOD Panchakarma
Affiliation
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar
Address
Room no.142 PG Department of Panchakarma Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar
Women of age 20- 40 years having Tubal block.
Patient having history of active marital life more than 1 year,
Patient diagnosed with tubal blockage (unilateral or bilateral) on the basis of
Hysterosalpingography(HSG).
• Patients irrespective of Primary and Secondary Infertilit
ExclusionCriteria
Details
1. Infertility due to another factor like uterine factor, cervical factor, peritoneal factor.
2. Infertility due to abnormality in male partner.
3. Patient diagnosed from chronic diseases like Hypertension, Diabetes mellitus,
Malignancy,Tuberculosis,Endometriosis etc.
4. Patient diagnosed from Hepatitis B, sexually transmitted diseases, human
immunodeficiency virus (HIV).
5. Congenital anatomical defect of female genital organ
6. Surgical factors like Ovarian Tumor, Ovarian endometrioma, etc.
7. Contraindication of Uttar Basti (like Genital tract infection, heavy bleeding, etc.)
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Lasuna Taila Uttarbasti may show better efficacy than Apamarga Kshara Uttar
Basti in the Management of Bandhyatwa (Tubal Blockage Infertility) showing conception of patient.
0th day,after 1st,2nd and 3rd menstrual cycle.
Secondary Outcome
Outcome
TimePoints
Uttar basti may result conception.
0th day and 3rd cycle
Target Sample Size
Total Sample Size="32" Sample Size from India="32" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
25/04/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
1. INTRODUCTION: Infertility is a condition which affects the psychological as well as physiological well-being of a woman. Inability to conceive even after one year of unprotected intercourse is considered as infertility.1 Infertility is one of the predominant health issues faced by married couple nowadays. It is common in 10-15% of couples, as per the current statistics male infertility problems constitutes 30-40%, female infertility problems constitute 40-55%2 , both are responsible in about 10% cases and remaining 10% unexplained. Among the causes of female infertility, one of the most common causes is considered to be the tubal factor. Infertility divided into 2 types: 1. Primary - patients who have never conceived. 2. Secondary - Indicates previous proven pregnancy but fails to conceive subsequently. Abnormality of tubes is generally of two types:3 (1) Structural - Anatomical blockage – (can be due to vitiation of Vata-Kapha / Pitta-Kapha) (2) Functional - Defect in ciliary function of tube – (can be due to vitiation of Vata) The obstruction of the tubes may be due to pelvic infections causing peritubal adhesions, Endosalphingeal damage, previous tubal surgery or sterilization, tubal endometriosis, polyps or mucous debris within the tubal lumen or tubal spasm.4 All types of female infertility in Ayurveda are described under the heading of Vandhya. It is one among 80 types of vataj disorders (Asheeti Vata Vikaras).5 Acharya Kashyapa opines that infertility occurs in couples due to their own deeds. During the period of Acharya Charaka, Infertile couples were considered as shadeless, branchless, fruitless waste tree or like a lamp in picture or portrait which will not emit any light or brightness.6 Infertility is termed as “Vandhyatva†and vitiation of Vata is the prime factor for initiation of disease. 2 In ‘Ayurveda’, the word “Yoni†refers to entire reproductive system, thus under this heading congenital or acquired diseases of anatomical components of reproductive organs i.e. vagina, cervix, uterus, endometrium, and fallopian tube can be included. धà¥à¤°à¥à¤µà¤‚चतà¥à¤°à¥à¤£à¤¾à¤®à¥à¤¸à¤¨à¥à¤¨à¤¿à¤§à¥à¤¯à¤£à¤¤ गरà¥à¤¾à¤¸à¥à¤¯à¤£à¤¨à¥à¤¿à¤¨à¥à¤¿à¤ªà¥‚वाकं। ऋतà¥à¤•à¥à¤·à¥‡à¤¤à¥à¤°à¤£à¤®à¥à¤¬à¥à¤¬à¥€à¤œà¤£à¤¿à¤£à¤®à¥à¤¸à¤£à¤®à¤—à¥à¤°à¤¯à¤£à¤¦à¤™à¤•à¥à¤°à¥‹ यथण।। (सà¥. सं.शण 2/33) According to Acharya Sushrut7 Ritu (Fertile period), Kshetra (Female reproductive organ should be normal) Ambu ((Proper nutrient fluid) and Beeja (Viable ovum and sperm) is essential factor for the proper conception, Absence or abnormality in any of the above factors may cause Vandhyatva. Among these factors, Beeja (ovum) is the core stone of the female reproductive process. Here Beeja is taken as Antahpushpa i.e., ovum. Thus, anovulation can be included under Beeja Dushti. Among these four factors tubal blockage can be considered as the deformity of Kshetra i.e., Kshetra Dusti. Correlating fallopian tubes with the Artavavaha (Artava-Beeja-Vaha) Srotas, its block can be compared as Sanga type of Srotodushti. “गरà¥à¤‚योनà¥à¤¿à¤¸à¥à¤¤à¤¦à¤£ शीघà¥à¤°à¤‚ नà¥à¤œà¤¤à¥‡à¤—हृणनà¥à¤¤ मणरूते†| (च.नà¥à¤¸.9/63) In the context of Uttar Basti Acharya Charaka has mentioned that once the Vata is controlled by Uttar Basti female achieves conception quickly.8 Acharya Charaka did not mention Vandhyatva in such a way, but if all the literature given by him is kept in a successive order, it can be divided in three types9 Vandhya - Here the Acharya has mentioned primary Infertility caused by congenital absence of uterus and or Artava. It denotes the condition of absolute sterility. This condition does not indicate Tubal Blockage directly. Apraja- Infertility in which woman conceives after treatment. This type of Infertility can be or cannot be due to Tubal Blockage, but it is not the direct indication of Tubal Infertility. 3 Sapraja - It is a condition in which a woman after giving birth to one or more children does not conceive in her reproductive age. This condition can be considered as a consequence of Tubal Infertility, because the post-partum infection of reproductive organs can cause Tubal Blockage. Harita Samhita is the only classic to have described the Bandhyatva as a disease entity. But Aacharya Harita has defined Bandhyatva as failure to get the child rather than conception, as he has included Garbhasravi (Habitual abortions) and Mritavatsa (still birth) also under his classification. Aacharya Harita has described 6 types of Bandhyatva10, which will be explained in the point of view of tubal blockage. Kakabandhya - secondary infertility - Woman, who does not conceive after giving birth to one child. Anapatya - primary infertility- A woman, who never conceives. Garbhasravi - A lady, who suffers from habitual abortions. Mritavatsa- A woman, who repeatedly gives birth to stillborn children. Dhatukshaya - A woman, who doesn’t conceive for losing the Bala or strength. Garbhasamkocha - Infertility caused by coitus in an Ajatarajasa (a girl before menarche). In Rasa Ratna samucchaya ,9 types of bandhya has been described Aadi bandhya , Rakta bandhya, Vata bandhya, Pitta bandhya, Kapha bandhya (due to obstruction), Tridosha bandhya, Deva bala, Gurujana, Apachara11 . 2 REVIEW OF LITERATURE Disease review The word Vandhya is derived from the root “Vandh†with “Yak†suffix, which means barren, unproductive, fruitless and useless. A woman in whom there is any kind of hindrance in normal process of conception is termed as Vandhya 11. Causes of Vandhyatava are Yoni Vyapath, Artava Vyapath, Vatavyadhi, Rasa Dusthi, Dhatu Kashya etc. Vitiation of Vata and Kapha lead to anovulation which is mentioned as amenorrhea, cessation of ovulation. Vitiated Vata dosha is the main cause of Vandhya yoni Vyapath, here Nashtartva is one symptom of the Vandhya. Intake of Apathya Ahara and Apathya vihara are also responsible for Vandhyatava. Due to Atiushna Annapana, Vishamashana, Adhyashana, Anashana, Virudhaannapana causes 4 Agnivaishamya and Rasadusti leads to Artava Dusthi ends with Beejarupi Artava Dushthi in the form of anovulation. The 4 factors of Garbha Utpatti are Ritu, Kshetra, Ambu, Beeja. Most important part among 4 has been considerd Beeja which is described as Streebeeja and Artava represents female hormones. Dhaturupa Artava which is responsible for yoni, Garbhashya, Stanavriddhi can be considered as ovarian hormones. Beejarupa Artava is expelled every month due to Pachana Karma of Pitta i.e., process of ovulation. So, anovulation comes under Beejadushti and is a cause for Stree Vandhyatva. Beejamsha Dushti is one of the causes for Stree Vandhyatva i.e., a part of Beeja, which is responsible for the development of uterus is defective, then born child would be Vandhya. In related with ovular factor the causes for anovulation include menstruating women can be a feature of hypothalamic anovulation, hyperprolactinaemia (due to drugs, pituitary adenoma or primary hypothyroidism), polycystic ovaries, subclinical adrenal failure and diabetes mellitus, luteinised unruptured follicles and luteal phase defect. 12 NEED OF STUDY: - Vandhyatva is the like curse to the woman and society as it affects her physical and mental health and there by the social life of the woman. Approximately 60-80 million couples suffering from infertility every year worldwide, probably between 15 and 20 million (25%) are in India alone. Over last decades, fertility therapy has expanded more than any other field of medicine. Hormonal therapy, In Vivo Fertilization (IVF), Embryo Transfer (ET), Gamete Intra Fallopian Transfer (GIFT) etc so many therapies are developed, but they have unsatisfactory results around 60%(https://www.novaivffertility.com/fertility-help/what-is-thr-ivf-success-rate-inindia) , enormous expenses and lots of side effects like ovarian hyper stimulation, frequent abortion, multiple gestations and major long-term possibility of ovarian cancer. Ayurveda may give a promising hand to cure this disease. So, the field of research in the Vandhyatva opens broad scope for a worker, hence this topic requires proper thought and operation in implementation of Ayurvedic treatment of success in aimed target of attaining twinkle in the eye of childless women. So, there is a great scope of research to find out safe, potent less costly and effective remedy for the management of Vandhyatva. Lasuna tail has vataghna properties as charaka mentioned vandhyatwa in vata vikara. 5 Lasuna has Madhura Vipaka which pacify vata , Due to katu rasa ,Tikshna guna it pacify vata and kapha, due to Tikshna and snigdha guna it will open the obstruction of channels. Uttar Basti is selected as a method of drug administration in case of tubal blockage for the present study. Uttar Basti is mostly used in all reproductive tract disorders. 3. RESEARCH QUESTION Does Lasuna Taila Uttarbasti has better efficacy than Apamarga Kshara Taila Uttar Basti in the Management of Bandhyatwa (Tubal Blockage Infertility) 4. HYPOTHESIS Lasuna Taila Uttar Basti has better efficacy than Apamarga Kshara Tail Uttar Basti in the Management. NULL HYPOTHESIS Lasuna Taila Uttar Basti is not effective as Aparmarga Kshara Tail Uttar Basti in the Management of Bandhyatwa (Tubal Blockage Infertility). ALTERNATE HYPOTHESIS Lasuna Taila Uttarbasti is effective as Apamarga Kshara Tail Uttar Basti in the Management of Bandhyatwa (Tubal Blockage Infertility) 5. PREVIOUS WORK DONE S.No Institute Ayurvedic Intervention Outcome Remarks 1 I.P.G.T & R.A, Gujarat Ayurveda University, Jamnagar in 2002 Prajasthapana gana siddha ghrita uttarabasti and oral prayoga 29% patients had ovulation while all the patients have shown increase in follicular size. 2 RGUHS, Karnataka, and Bangalore in 2013. To study the efficacy of Narayan taila uttara basti in female infertility out of 30 patients, 3.33% of patients i.e. one patient conceived. Complete remission i.e., ovulation was found in 30% of the 16.67% patients had no response 6 patients. While 56.67% of patients were reported with improvement 3 RGUHS, Karnataka Bangalore in 2016 Ashvagandha Ksheerapaka in Stree Vandhyatva w.s.r to Anovulation that out of 30 patients maximum 93.3% there was no change Study is not statistically significant 4 RGUHS, Karnataka, Bangalore in 2017 Puga Paka in the management of Stree Vandhyatva 26 patients maximum 47.61% there was no change observed in the growth of the follicles whereas in 33.3% there is slight improvement in follicular growth It is statistically significant 5 IPGT and RA Uttarabasti of Kumari Taila & Tila Taila in the management of bandhyatva Among 26 registered patients, i.e. 40% positive result was found in secondary infertile patients, where as 42.86% in primarily infertile patients. 6 IPGT and RA Jamnagar 2010 Uttar basti of Yava kshara taila and kumari taila Blockage was removed in 85 % 7 IPGT and RA Jamnagar 2014 Uttar basti of kumari taila and tila taila Blockage opened in 33% Conception rate only in 25% 8 IPGT and RA Jamnagar 2015 Uttar basti of Apamarga kshara taila and phala kalyana ghrita Blockage opened in 75 % 9 Sri kalabraveshwara Patient conceived 7 swami ayurvedic medical college and Reseaech centre 10 IPGT and RA Jamnagar Krishna taila and Arkapushpa Taila uttar basti 80% of patients completely cured 11 Govt. Ayurvedic P.G college Chaukaghat ,uttarpradesh Dhanwantara Tail Uttar Basti Patients cured 6. AIM AND OBJECTIVES AIM: To compare the efficacy of Lasuna Tail Uttar Basti and Apamarga Kshara Tail Uttar Basti in Management of Bandhyatwa (Tubal Blockage Infertility) OBJECTIVE: -To evaluate the efficacy of Lasuna Tail Uttarbasti in Bandhyatwa (Tubal Blockage Infertility) -To evaluate the efficacy of Apamarga Kshara Taila Uttar Basti in Management of Bandhyatwa (Tubal Blockage Infertility) 7. SAMPLE SELECTION DIAGNOSTIC CRITERIA: Patients will be assessed on the basis of Hysterosalpingogram. INCLUSION CRITERIA: - Womens of age 20- 40 years having Tubal block. -Patient having history of active marital life more than 1 year, -Patient diagnosed with tubal blockage (unilateral or bilateral) on the basis of Hysterosalpingography(HSG). - Patients irrespective of Primary and Secondary Infertility. 8 EXCLUSION CRITERIA: - 1. Infertility due to another factor like uterine factor, cervical factor, peritoneal factor. 2. Infertility due to abnormality in male partner. 3. Patient diagnosed from chronic diseases like Hypertension, Diabetes mellitus, Malignancy,Tuberculosis,Endometriosis etc. 4. Patient diagnosed from Hepatitis B, sexually transmitted diseases, human immunodeficiency virus (HIV). 5. Congenital anatomical defect of female genital organ 6. Surgical factors like Ovarian Tumor, Ovarian endometrioma, etc. 7. Contraindication of Uttar Basti (like Genital tract infection, heavy bleeding, etc.) WITHDRAWAL CRITERIA - Patients willing to quit in between will be allowed to quit & will be replaced. -If any acute illness or serious adverse effect develops, patient will be treated accordingly and will be excluded from study 8. MATERIALS AND METHODS STUDY DESIGN- Randomised control trial STUDY POPULATION-POPULATION-Patients of Bandhyatwa fulfilling the Inclusion criteria will be selected from OPD And IPD of Ch. Brahm Prakash Ayurveda Charak Sansthan, Khera Dabar, New Delhi. STUDY SETTINGOPD and IPD of Ch. Brahm Prakash Ayurveda Charak Sansthan, Khera Dabar, New Delhi. SAMPLE SIZE -32 (16 in each group) STUDY PERIOD -3 menstrual cycles 9 SAMPLE SIZE CALCULATION Calculated by given below formula using assumed mean difference. Type of Study Randomized control trial with comparator group Type of Outcome Variable Change in area covered measure by transparent graph paper. Alpha (α) 1.96 Beta (β) 0.8 Standard deviation of Group A 0.4 Standard Deviation of Group B 0.4 Assumed Mean Difference 0.4 Power 80% or 0.8 Drop out % 25 % The standard deviation 0.4 has been taken from an earlier study on the “Management of female infertility w.s.r to tubal blockage by Uttarbasti with Apamarga kshara taila and phalakalyana ghrita†SAMPLE SIZE=32(16 in each group) STATISTICAL ANALYSIS: Data collected through predefined registration Performa, follow up and assesement. It will be analysed statistically by appropriate student t-test. 10 GROUPING The selected patients will be grouped into two categories by using computerized random sampling method. -Group-A: Lasuna Tail Uttarbasti • Group-B: Apamarga Kshara Tail Uttarbasti GROUPING GROUP -A APAMARGA KSHARA TAILA (CHAKRADATTA KARNA ROGA 57/25) INGREDIENTS: DRUG LATIN NAME PART Apamarga Achyranthas aspera Linn. Apamarga Kalka 1/4 part + Apamarga Kshara Jala 4 part Tila Sesame indicum Tila Taila 1 part GROUP-B LASUNA TAILA(KASHYAP SAMHITA KALPASTHAN 2/98) DRUG LATIN NAME PARTS Lasuna Alium sativum 100 Mudgaparni Phaseolus trilobus 1 Mashaparni Teramnus labialis 1 Jivanti Leptadenia reticulata 1 Madhuyashti Glycyrrhiza glabra 1 11 Musta Cyperus rotundus 1 Haridra Curcuma longa 1 Pippali Piper longum 1 Shunthi Zingiber officinale 1 Ajmoda Trachyspermum roxburghianum 1 Amalaki Emblica officinalis 1 Vibhitaka Terminalia bellirica 1 Haritaki Terminalia chebula 1 Ativisha Aconitum heterophyllum. 1 Ashwagandha Withania somnifera 1 Bilba Aegle marmelos 1 Shyonak Oroxylum indicum 1 Brihati Solanum indicum 1 Kantakari Solanum surattense 1 Gambhari Gmelina arborea 1 Patala Stereospermum suavelens 1 Gokshura Tribulus terristris 1 Agnimantha Premna mucronata 1 Salparni Desmodium gangeticum 1 Prisnaparni Uraria picta 1 12 Uttar Basti with Lasuna Taila and Apamarga Kshara Taila in respective groups. Drug : Lasuna taila Mode of administration : Taila Dose : 5 ml Route : Intra uterine Duration : Each cycle for 3 days after menstruation (between 7th to 10th day of cycle for 3 cycles) Group A TIME 1 st Day 2 nd Day 3rd Day 4 th Day Morning Anuvasan basti with Murchita Tila Taila Niruha Basti by Erandamooladi kwatha Niruha Basti by Erandamooladi kwatha Niruha Basti by Erandamooladi kwatha Afternoon Uttar Basti by Lasuna Taila Uttar Basti by Lasuna Taila Uttarbasti by Lasuna Taila Group B TIME 1 st Day 2 nd Day 3rd Day 4 th Day Morning Anuvasan Basti with Murchita Tila Taila Niruha Basti by Erandamooladi Kwatha Niruha Basti by Erandamooladi Kwatha Niruha Basti by Erandamooladi Kwatha Afternoon Uttar Basti by Apamarga Kshara taila Uttar Basti by Apamarga Kshara taila Uttar Basti by Apamarga Kshara taila 13 SCHEDULE OF THE STUDY Day 0 1 st cycle 2 nd cycle After 3rd cycle Screening ✓ Assessment ✓ ✓ Follow up ✓ ✓ ✓ Observation ✓ ✓ ✓ ✓SCREENING TEST: CBC LFT KFT ESR RBS VDRL HBsAG ASSESSMENT CRITERIA: Patients will be assessed on the diagnosis of Hysterosalpingraphy or patients conceived. EXPECTED OUTCOME: Lasuna Taila Uttarbasti may or may not show better efficacy than Apamarga Kshara Uttar Basti in the Management of Bandhyatwa (Tubal Blockage Infertility) KEY WORDS Bandhyatwa, Lasuna Taila, Uttar Basti, Tubal Blockage Infertility, Apamarga Kshara Taila