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CTRI Number  CTRI/2025/09/094437 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study To Assess The Effect Of Ayurvedic Treatment Virechana And Dooshivishari Agada In Women With Repeated Pregnancy Loss 
Scientific Title of Study   Efficacy Of Virechana And Oral Dooshivishari Agada In Garbhasravi Vandhyatva Recurrent Pregnancy Loss A Single Arm Interventional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MUSKAN JAIN 
Designation  PG SCHOLAR 
Affiliation  All INDIA INSTITUTE OF AYURVEDA SARITA VIHAR NEW DELHI 110076 
Address  405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076
405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076
South
DELHI
110076
India 
Phone  09911550280  
Fax    
Email  mjmuskan763@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MEETA JHALA 
Designation  ASSISSTANT PROFESSOR 
Affiliation  All INDIA INSTITUTE OF AYURVEDA SARITA VIHAR NEW DELHI 110076 
Address  405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076
405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076
South
DELHI
110076
India 
Phone  8107415431  
Fax    
Email  meetajiten6978@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR MUSKAN JAIN 
Designation  ASSISSTANT PROFESSOR 
Affiliation  All INDIA INSTITUTE OF AYURVEDA SARITA VIHAR NEW DELHI 110076 
Address  405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076
405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076
South
DELHI
110076
India 
Phone  8107415431  
Fax    
Email  meetajiten6978@gmail.com  
 
Source of Monetary or Material Support  
405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF AYURVEDA 
Address  405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India 
Type of Sponsor  Government medical college 
 
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 MUSKAN JAIN  OPD 203 All India Institute Of Ayurveda   405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076
South
DELHI 
9911550280

mjmuskan763@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIA INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N96||Recurrent pregnancy loss. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म Pradhan Karma(Procedure Reference: charak siddhi 1, Procedure details: Virechana will be done on third day with Trivrit Avaleha in the doze of 30-60 gm with anupana Triphala kwatha 100ml)
(1) Medicine Name: trivrita avleha, Reference: AHK 2 9-10, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days
2Intervention ArmDrugClassical(1) Medicine Name: dooshivishari agada, Reference: A.H.U. 35 39, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Married female patients of child bearing age of 20 40 years
Patients of secondary infertility having history of recurrent pregnancy loss more than or equals to 2 in first trimester
Patients willing to enrol in the study
Patients who are eligible for Virechana
Patients with normal husband semen analysis
 
 
ExclusionCriteria 
Details  Patients suffering from any chronic debilitating disease like diabetes mellitus hypertension sexually transmitted disease hepatitis B and AIDS
Uncontrolled hypothyroidism hyperthyroidism
Patient having any anatomical defect in reproductive system
Patients with positive TORCH IgM
Patients who are not eligible for Virechana
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increasing incidence of successful conception in patients with pregnancy loss during treatment and successful sustaining of pregnancy till First Trimester with the three month followup period  Baseline
3 Months
6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
The therapeutic integration of Virechana, Dooshivishari Agada is anticipated to improve reproductive health by restoring ovulatory function, menstrual irregularities, reproductive hormonal imbalance.   6months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   15/11/2025 
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="30" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

RESEARCH QUESTIONWhat is the impact of Virechana with Trivrit Avaleha, Dooshivishari Agada orally on conception and pregnancy continuation in Garbhasravi Vandhyatva Recurrent Pregnancy Loss in First Trimester

NULL HYPOTHESISThe administration of Virechana with Trivrit Avaleha, oral administration of Dooshivishari Agada 500 mg 2 tablets BD for 3 months has no significant effect on conception and pregnancy continuation in women diagnosed with Garbhasravi Vandhyatva Recurrent Pregnancy Loss in First Trimester

 ALTERNATE HYPOTHESIS The administration of Virechana with Trivrit Avaleha, oral administration of Dooshivishari Agada 500 mg 2 tablets BD for 3 months  has significant effect on conception and pregnancy continuation in women diagnosed with Garbhasravi Vandhyatva  Recurrent Pregnancy Loss in First Trimester

Need of the Study Recurrent Pregnancy Loss affects 2percent–5percent of couples and remains unexplained in nearly 50percent of cases Current modern medical approaches such as hormonal therapy, anticoagulants, and surgery often fail to provide satisfactory outcomes in these unexplained cases Ayurveda offers holistic protocols like Virechana and oral Vishahara therapy Dooshivishari Agada which are traditionally used to detoxify the body improve uterine health and enhance fertility However there is a lack of clinical evidence supporting their efficacy in RPL This study aims to bridge that gap by scientifically evaluating Ayurvedic protocols using modern diagnostic tools and outcome measures

OBJECTIVES To evaluate the efficacy of Virechana Dooshivishari Agada improving conception rates and pregnancy continuation in women with Garbhasravi Vandhyatva Recurrent Pregnancy Loss

 Primary To assess the efficacy of Virechana Dooshivishari Agada in enhancing conception rates and successful continuation of pregnancy till First Trimester among patients experiencing Garbhasravi Vandhyatva Recurrent Pregnancy Loss

 Secondary To evaluate the therapeutic benefits of Virechana Dooshivishari Agada on Garbhasravi Vandhyatva Recurrent Pregnancy Loss in first trimester to improve reproductive health by restoring ovulatory function menstrual irregularities reproductive hormonal imbalance

Research Methodology

This is a single group prospective clinical interventional study
Sample size will be 30 women with a history of recurrent pregnancy loss of more than or equals to 2 in the first trimester
Eligible participants will receive Virechana using Trivrit Avaleha followed by oral administration of Dooshivishari Agada 500 mg 2 tablets twice daily for 3 months
Patients will be recruited from the OPD of the Striroga Evam Prasuti Tantra department at AIIA Sarita Vihar

Follow up study will be conducted for either three cycles after completion of the treatment or till the sustainability of first trimester of pregnancy

If patient got conceived then the routine antenatal care will be followed

end point will be uneventfull completion of first trimester of pregnancy

Inclusion Criteria

Married females aged 20 to 40 years

History of two or more first-trimester pregnancy losses

Willingness to participate and provide informed consent

Normal semen analysis of the husband

Fit for Virechana therapy

Exclusion Criteria

Chronic systemic illnesses such as diabetes hypertension HIV hepatitis B or STDs

Uncontrolled thyroid disorders

Anatomical abnormalities in the reproductive tract

TORCH IgM positive cases

Unfit for Virechana

Investigations to be Done

before and after treatment 

USG pelvis and obstetrics

Transvaginal sonography for follicular study

Serum hormone profile Progesterone Estrogen FSH LH Prolactin

APLA profile quantitative

TORCH profile quantitative

CBC with ESR

LFT KFT

before treatment 

Urine routine and microscopy

TB Gold

HSG

HIV 1 & 2 HBsAg Anti HCV VDRL

Husband semen analysis

thyroid profile 

Assessment Criteria

Subjective Criteria

Sustaining of pregnancy through the first trimester

Menstrual parameters such as duration of bleeding cycle interval and flow during menstruation

Objective Criteria

Follicular development and ovulation via TVS

Endometrial thickness on day 14

Hormonal levels FSH LH estrogen progesterone prolactin


 
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