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CTRI Number  CTRI/2024/05/066883 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   An Ayurvedic treatment protocol for the management of female infertility (Vandhytava) due to low anti-mullerian harmone 
Scientific Title of Study   Efficacy of Virechana,Shatpushpa Yapana Basti,Phalkalyan Ghrita Uttara Basti,Shatpuspa Taila Nasya along with Lakshmana Churna orally in the management of female infertility (Vandhytava) w.s.r. to low AMH - An open labelled single arm clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kusum Kumari 
Designation  M.S. scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar. 
Address  Department of prasuti tantra evum stree roga,5th floor, academic building, Institute of teaching and research in ayurveda, Jamnagar.

Jamnagar
GUJARAT
361008
India 
Phone  7073076929  
Fax    
Email  kusumrangi245@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  vd Grishma Solanki 
Designation  Lecturer 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427753900  
Fax    
Email  grishmabams@gmail.com  
 
Details of Contact Person
Public Query
 
Name  vd Grishma Solanki 
Designation  Lecturer 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar


GUJARAT
361008
India 
Phone  9427753900  
Fax    
Email  grishmabams@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar  
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Opp. B-Division Police Station, Gurudwara Road Jamnagar, Gujarat 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kusum Kumari   PG Hospital, Institute of Teaching and Research in Ayurveda Jamnagar   OPD no.07, PG Hospital, Institute of Teaching and Research in Ayurveda Jamnagar, GUJARAT
Jamnagar
GUJARAT 
7073076929

kusumrangi245@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamanagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N978||Female infertility of other origin. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Chakrapani Charak Siddhi, Procedure details: Local Abhyanga & Swedana at Kati, Prushtha and Adhodara Pradesha, Yoniprakshalana With Triphala kwath Uttara Basti.This procedure will be done for 6 days once in a Day.)
(1) Medicine Name: Phalakalyana Ghrita Uttarbasti, Reference: : Bhaishajya Ratnawali Yonivyapada Chikitsa, , Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 6 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charak Siddhi Sthana, Procedure details: Local Abhyanaga & Swedana at Urdhwajatrugata Pradesha, Nasya Karma.This Procedure will be done for 2 Consecutive cycle. 8 Drop in each nostrils.)
(1) Medicine Name: Shatapushpa Taila , Reference: Sharangdhara Samhita Madhyama Khanda , Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
3Intervention ArmDrugClassical(1) Medicine Name: Lakshmana Churna, Reference: Yoga Ratnakar Yonivyapada Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Months, anupAna/sahapAna: Yes(details: -Go- Dugdh), Additional Information: -All the interventions are given in single group.
4Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Kashyapa Samhita Siddhi Sthana, Procedure details: Deepan Pachan for 5 to 7 days, Snehpana with Go-ghrit As per koshtha & agni, Abhayang and swedan for 4 days, virechana karma for 1 day ,sansarjana karma as per koshtha sudhi ))
(1) Medicine Name: Trivruta Avalaha, Reference: Ashtang Hridaya kalpa sthan 2/9, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 1 Days
5Intervention ArmProcedure-yApana-bastiH, यापन-बस्तिः (Procedure Reference: Charak Samhita Sidhi Sthana, Procedure details: Sthanik Abhayang & Swedan at Adhoudara,and Kati Pradesh, Yapan Basti. This procedure will be done for 7 days empty stomach in the morning )
(1) Medicine Name: Shatpushpa Yapana Basti, Reference: Charak Samhita Sidhi Sthana, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 650(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Married female patients of reproductive age 20-
40 years with complain of infertility.
2.Patients with AMH level less than 2.2
3.Patients with AFC less than 8
4.Patients eligible for Virechana, Yapan Basti,
Uttar Basti and Nasya Karma.
Patients willing to participate in trial.
 
 
ExclusionCriteria 
Details  1.Unmarried female patients of reproductive age
below 20 and above 40.
2.Patients with AMH more than or equal to 2.2
3.Patient with AFC more than or equal to 8
4.Patients are not eligible and willing for
procedure
Patients willing to participate in trial.
Suffering from malignancies and chronic systemic diseases like, uncontrolled hypertension (Systolic blood pressure above 160 & Diastolic blood pressure above 100mmhg), uncontrolled diabetes (above the range of 160-200 mg/dl (RBS), Hepatitis C, Hepatitis B etc..
Patient with infectious diseases of the reproductive tract like tuberculosis and sexually transmitted diseases.
Patient with polycystic ovarian syndrome (PCOS).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the level of AMH.
Improvement in the AFC.
 
5 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Correct menstrual abnormality.
induce ovulation
Achieve conception
 
5 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   15/05/2024 
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="6"
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  

INTRODUCTION:-

Infertility is defined as not being able to get pregnant or conceive after one year or longer time period of unprotected vaginal intercourse.

The most common overall cause of female infertility is the failure to ovulate, which occurs in 40% of women with infertility issues.

Poor Ovarian Reserve (POR) indicates a reduction in the quantity of ovarian follicular pool in women of reproductive age group and it is an important cause of infertility due to failure to ovulate in many couples.

Anti Mullerian Hormone (AMH) is considered as a marker for the ovarian reserve, as it has a regulative function in the activation of folliculogenesis and has an influence on atresia rate.

In women, an AMH level can provide information about the fertility status and the ability to get pregnant. The term ovarian reserve describes the number and the quantity of  the remaining oocytes in the follicles.

According to Acharya Sushruta, there are four factors responsible for creation of Garbha i.e. Rutu (ovulatory period/ period for copulation), Kshetra (reproductive tract including uterus, fallopian tube, ovary), Ambu (nutritive fluid for fertilized ovum), Beeja (Shukra & Shonita i.e. sperm & ovum). Among these four factors low AMH can be considered as the deformity of Beeja i.e. Beejadusti. Beeja is the corestone of female reproductive process and in its absence conception cannot achieve despite of all other factors, here Beeja is taken as Antahpushpa i.e., ovum.

Rationale for selection of the topic

AMH level is indicative of ovarian response, its measurement becomes an inevitable criteria before IVF. Considering the high cost and possible complications of ART procedures, the unavoidable role of AMH as a superior candidate predicting ovarian reserve has been explored in various studies.

Therefore, uncertainty in the ART procedure outcome can be minimized to a greater extent. Reports suggest that patients with a diminished ovarian reserve have the only option of IVF with a donor egg. The occurrence of poor ovarian response in IVF ranges from10 to 20%.

The clinical symptoms observed in the infertility with low AMH resembles to Dhatukshayajanya Vandhyatva (infertility due to depletion of body tissues), that has been already explained in Ayurveda in Harita Samhita.

The role of an effective Ayurvedic treatment protocol to improve the AMH level to a satisfactory level to have a better response to ovarian stimulation for normal conception or IVF by own eggs, thereby opening a scope of an integrated medical approach. The present study is an attempt on the same

 

AIM :-

To evaluate the efficacy of Virechana, Shatpushpa Yapana Basti, Uttara Basti with Phalakalyan Ghrita, Nasya with Shatapushpa Taila along with oral administration of Lakshmana Choorna in the management of female infertility (Vandhytava) due to low AMH.

Objectives:

To evaluate the effect of  trial drug in improving the AMH (Anti Mullerian Hormone) level.

To evaluate the effect of trial drug in improving the AFC (Antral Follicle Count).

 

Materials and Methods

In this study there is only one group containing 15 patients and will be treated with in first month Virechana Karma will be done.In second month Shatpushpa Yapan Basti (7 days) will be done.In third month Phalkalyan Ghrita Uttarbasti (6 days) will be done.In forth and fifth month Shatpushpa Taila Nasya ( 7 days and will repeat this  for 2 consecutive ctyclcles) will be done along with Lakshamana Choorna orally for 5 month.

Results and Discussion:

Data generated during the above study will be presented in a systemic manner and shall be analysed statistically. The important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Side Effects: This drug has no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.


 
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