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CTRI Number  CTRI/2024/03/064311 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of Vandhyatva (female infertility) due to anovulatory factor associated with obesity 
Scientific Title of Study   Efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally in the management of Vandhyatva (Female Infertility) due to anovulatory factor associated with obesity: A single arm open labelled 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  Alifeeya Mohammad Hussain Vaghela 
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  8511607252  
Fax    
Email  alifeeya.vaghela@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa B Donga 
Designation  Professor [I/C HOD] 
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  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shilpa B Donga 
Designation  Professor [I/C HOD] 
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  9825646796  
Fax    
Email  drshilpadonga@yahoo.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,Gujrat361008 
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 Alifeeya Mohammad Hussain Vaghela  PG Hospital, Institute of Teaching and Research in Ayurveda, Jamnagar  OPD no. 07,PG Hospital, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujrat
Jamnagar
GUJARAT 		 8511607252

alifeeya.vaghela@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, Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Kashyapa Samhita , Procedure details: Deepana-Pachana for 5-7 days, Snehapana until Samyaka Snigdha Lakshana is obtained, Sarvanga Abhyanga and Swedana for 4 days, Virechana Karma 1 day, Sansarjana Krama as per Shudhdhi )
(1) Medicine Name: Trivrutta Avaleha, Reference: Ashtanga Hridaya Kalpasthana Adhyaya 2, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Kashyapa Samhita Kalpa Sthana Adhyaya 2, Procedure details: local Abhyanga and Swedana at Kati, Adhodara and Prushtha Pradesha, Matra Basti)
(1) Medicine Name: Lashunadi Taila, Reference: Kashyapa Samhita Kalpa Sthana Adhyaya 2, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
3Intervention ArmDrugClassical(1) Medicine Name: Guduchi-Mustadi Kashaya, Reference: Charaka Samhita Sutra Sthana Adhyaya 21, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients willing to give written informed consent by themselves.
Infertile female patients of reproductive age more than or equal to 20 years and less than or equal to 40 years.
Patients who have age less than 35 years completed active married life of minimum 1 year duration and patients aged 35 years or more completed active married life of 6 months suffering from Infertility with 2 or more consecutive anovulatory cycles.
Patients having class I obesity - overweight (BMI 25.0-29.9 kg/m2), class II obesity - obesity (BMI 30.0-39.9 kg/m2).
Primary and secondary infertile patients having anovulatory cycle or immature ovarian follicle.
Patient eligible & willing for Virechana Karma and Matra Basti.
 
 
ExclusionCriteria 
Details  Patients with infectious diseases of the reproductive tract like tuberculosis and sexually transmitted diseases.
Organic lesions of the reproductive tract like carcinoma and congenital deformities.
Patients with history of cardiac diseases, Uncontrolled Diabetes (above 200 mg/dl- RBS) & Hypertension (Systolic BP above 160 & Diastolic above 100mmhg), etc.
Patients with Hepatitis C, Hepatitis B.
Patients are not eligible for Virechana Karma and Matra Basti.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is expected that the trial protocol will induce ovulation.
It is expected that trial protocol will help to reduce the BMI of patient.

 		 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Trial protocol will cure menstrual abnormalities associated with anovulation like irregular, scanty/ excessive menstruation and dysmenorrhea.
Improvement in quality of life.
 		 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 27/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction:The WHO defines infertility as ‘A disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse and there is no other reason, such as breastfeeding or postpartum amenorrhoea.’ The relationship between obesity and reproductive functions has been known for many years and it is still being explored. According to American Society for Reproductive Medicine (ASRM) obesity is the cause of fertility struggle in 6% of women who have never been pregnant before. In Sthaulya, there is abnormal and excess accumulation of Medodhatu, where in only Medodhatu is nourished and other Dhatus are deprived of nourishment. According to Acharya Sushruta, Sthaulya is a Rasanimittaja Vikara and Artava being Upadhatu of Rasa Dhatu also gets affected and leads to anovulation and menstrual abnormality.

In this study, Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally has been included. Virechana is effective as it works as Srotoshodhana and Kaphahara. By Virechana Karma all Srotas especially Medovaha and Rasavaha Srotas gets purified. Matra Basti given through Guda (rectal route) normalizes Apana Vayu leading to Vatanulomana and physiological functioning of Vata, which may help in turn for the extrusion of ovum from the follicle and ovulation. Guduchi-Mustadi Kashaya contains Guduchi, Musta which encounters Vata and Kapha Dosha by virtue of its Katu, Kashaya-Rasa dominance and Ushna-Veerya. Katu-Rasa performs Medo-Kledopa-Shoshana action. Triphala also having Meda-Kaphahara properties along with it enhances Agni.

AIM:

To evaluate the efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally is effective in the management of female infertility due to anovulatory factor associated with obesity.

OBJECTIVES:

1.     To assess the efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally on follicular growth and rupture of follicle.

2.     To assess the efficacy of Virechana Karma, Lashunadi Taila Matra Basti along with Guduchi-Mustadi Kashaya orally on BMI.

Materials and Methods:In the present study total 20 Clinically diagnosed and registered patients of Anovulation, fulfilling the criteria of inclusion will be registered. In 1st month, All the patients will be given Virechana Karma after the cessation of menstruation. In 2nd-3rd month Matra Basti with Lashunadi Taila 7days, after cessation of menses for 2 consecutive cycles along with Guduchi-Mustadi Kashaya (40ml) orally twice a day, before meal will be given.

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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