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CTRI Number  CTRI/2025/08/092998 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Controlled Clinical Trial To Evaluate The Effect Of Mudgadya Ghrit Uttarbasti and Apamarg Kshar Taila Uttarbasti in the Management of Adenomyosis Or Vataja Asrigdar  
Scientific Title of Study   A Randomized Open Label Controlled Clinical Study to Evaluate the Efficacy of Mudgadya Ghrit Uttarbasti and Apamarg Kshar Taila Uttarbasti in the Management of Vataja Asrigdar w.s.r Adenomyosis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prajkta Gajanan Chaudhari  
Designation  PG Scholar Stree Roga Prasuti Tantra  
Affiliation  Institute for Ayurved Studies and Research  
Address  Opd No 15 Department of Stree Roga Prasuti Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9373147883  
Fax    
Email  prajktachaudhari799@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitesh Kumar Panda  
Designation  Chairperson  
Affiliation  Institute for Ayurved Studies and Research  
Address  Room No 112 PG Department of Stree Roga Prasuti Tantra Institute for Ayurved Studies and Research Umri Road Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9896033056  
Fax    
Email  drjk67@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prajkta Gajanan Chaudhari  
Designation  PG Scholar Stree Roga Prasuti Tantra  
Affiliation  Institute for Ayurved Studies and Research  
Address  Opd No 15 Department of Stree Roga Prasuti Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9373147883  
Fax    
Email  prajktachaudhari799@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra  
 
Primary Sponsor  
Name  Institute for Ayurved Studies and Research  
Address  Sector 8 Umri Road Kurukshetra Pin136118  
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 Prajkta Gajanan Chaudhari   Institute for Ayurved Studies and Research   Opd No 15 Department of Stree Roga Prasuti Tantra Institute for Ayurved Studies and Research Umri Road Sector 8
Kurukshetra
HARYANA 
9373147883

prajktachaudhari799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttarabastikarma, उत्तरबस्तिकर्म (Procedure Reference: Charak Samhita , Procedure details: 20 patients will be treated with Mudgadya Ghrit Uttarbasti after complete cessation of menses for 3 days for 3 consecutive cycles Dosage 5 ml)
(1) Medicine Name: Mudgadya Ghrit , Reference: Yogaratnakar Chapter Stree Rogadhikar Pradar Roga Chikitsa Verse 1 , Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Months
2Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak Samhita , Procedure details: 20 patient will be treated with Apamarg kshar Taila Uttarbasti after complete cessation of menses for 3 days for 3 consecutive cycles Dosage 5 ml)
(1) Medicine Name: Apamarg Kshar Taila, Reference: Chakradatta Karnarog Chikitsa Chapter 57/25, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1 Married female Patients of age between 21 to 50years
2 Patients willing to participate in Clinical Trial
3 Patient having Heamoglobin greater than 7gm percent
4 Patients having symptoms of AUB or frothy bleeding or Menorrhagia with one all the following symptoms such as dysmenorrhea dyspareunia and known case of Adenomyosis confirmed by any diagnostic technique
5 Patients are Yogya for Uttarbasti procedure

 
 
ExclusionCriteria 
Details 
1 All pregnant women
2 Patients not willing for trial
3 Patient having Systemic Disease like Diabetes FBS greater than 125 mg per dl,Hypertension greater than 140 by 90mm of Hg,Severe Anemia Hb less than 7 gm percent
4 Patients having coagulation disorders, cardiovascular disorders, Cerebrovascular accidents
5 Patients suffering from Malignancy
6 Patient with congenital anamoly of reproductive tract
7 Acute inflammatory disease like Sexual Transmitted Disease like HIV, VDRL,HBsAg, HCV positive females
8 Patient Ayogya for Uttarbasti procedure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 To improve the grading of Menorrhagia   Follow up will be done on 30,60,90,120 days 
 
Secondary Outcome  
Outcome  TimePoints 
1 Improvement in the Heamoglobin level
2 To resolve MUSA Criteria for Adenomyosis  
Follow up will be done on 90 day & 1 more follow up on 120 day After completion of trail  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   01/12/2025 
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="0" 
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
Modification(s)  
PRIMARY PURPOSE IS TREATMENT 
ADENOMYOSIS IS A CONDITION WHERE THERE IS A INGROWTH OF ENDOMETRIUM DIRECTLY INTO THE MYOMETRIUM. PREVALENCE OF ADENOMYOSIS  IN CASE OF ENDOMETRIOSIS IS 70 PERCENT AND THE PREVALENCE IS FOUND TO BE 23.5 PERCENT IN PATIENTS WHO HAD COMPLAIN OF MENORRHAGIA 70 PERCENT  FOLLOWED BY DYSMENORRHEA  30 PERCENT.  THE PATIENTS ARE USUALLY PAROUS 90 PERCENT  WITH ABOVE AGE 40. THE PATIENT WITH ADENOMYOSIS  USUALLY PRESENT WITH MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA , INCREASE THE FREQUENCY OF MICTURITION AND INFERTILITY. IN MODERN MEDICINE,  THE MAIN OBJECTIVE OF MANAGEMENT IS  RELIEF FROM PAIN AND REDUCTION OF EXCESSIVE MENSTRUAL BLEEDING.  MOSTLY USE NSAIDS AND HORMONAL THERAPIES AND LAST OPTION IS HYSTERECTOMY.  HOWEVER  LONG TERM USE OF THESE MEDICATIONS  MAY LEAD TO ADVERSE EFFECTS  ON WOMENS HEALTH. AYURVEDA AS A HOLISTIC SCIENCE AND WAY OF LIVING OFFERS PROMISING ALTERNATIVE  TREATMENT MODALITIES THAT CAN POTENTIALLY  REPLACE OR COMPLEMENT ALLOPATHIC APPROACHES WHILE MINIMIZING HARMFUL SIDE EFFECTS. 
                            IN VIEW OF THIS EFFECT OF MUDGADYA GHRIT UTTARBASTI AND APAMARG KSHAR TAILA UTTARBASTI IN THE MANAGEMENT OF ADENOMYOSIS WSR VATAJA ASRIGDAR. THIS STUDY INVOLVES 40 PATIENTS.  THESE 40 PATIENTS  ARE DIAGNOSED WITH  ADENOMYOSIS  BASED ON CLINICAL EVALUATION AND SUPPORTING INVESTIGATIONS. MUDGADYA GHRITA  AND APAMARG KSHAR TAILA ARE DIVIDED INTO 2 GROUPS . THIS WILL BE ADMINISTERED FOR 3 MONTHS IN FORM OF UTTARBASTI  AFTER CESSATION OF MENSES AIMING TO RESOLVE THE SYMPTOMS OF ADENOMYOSIS SUCH AS MENORRHAGIA,  DYSMENORRHEA  AND OTHER SYMPTOMS  RESOLVE MUSA CRITERIA FOR ADENOMYOSIS . OUTCOME MEASURE WILL INCLUDES BOTH SUBJECTIVE AND OBJECTIVE PARAMETERS. ALTHOUGH, ADENOMYOSIS IS NOT DIRECTLY CORRELATED WITH ANY DISEASE IN AYURVEDA BUT ON THE BASIS OF SYMPTOMS ADENOMYOSIS CAN BE CORRELATED WITH VATAJA ASRIGDAR. THIS STUDY AS TO PROVIDE AN EASY AND POTENTIALLY SAFER ALTERNATIVE TO CONVENTIONAL TREATMENT. 
                      
 
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