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CTRI Number  CTRI/2026/02/104447 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study Comparing Two Ayurvedic Herbal Medicines with Medicated Oil Enema Therapy in Uterine Fibroids. 
Scientific Title of Study   A Randomized Comparative Exploratory Clinical Trail to Evaluate The Efficacy of Ashoka Twak Ghana Vati and Kanchanar Twak Ghana Vati Along With Darvyadi Kwath Siddha Taila Matra Basti On Garbhshaya Arbuda W.S.R. To Uterine Fibroid. 
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 Aditi Jain 
Designation  M.S. Scholar 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G.Department of Prasuti Tantra Evam Strirog ,Madan Mohan Malviya Govt. Ayurvedic College, Ambamata, Udaipur Rajasthan,India

Udaipur
RAJASTHAN
313301
India 
Phone  7339883414  
Fax    
Email  jaditi1203@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrNarendra Kumar Meena  
Designation  Associate Professor 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G.Department of Prasuti Tantra Evam Strirog ,Madan Mohan Malviya Govt. Ayurvedic College, Ambamata, Udaipur Rajasthan,India

Udaipur
RAJASTHAN
313301
India 
Phone  9950129673  
Fax    
Email  narendermeena42@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrNarendra Kumar Meena  
Designation  Associate Professor 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  P.G.Department of Prasuti Tantra Evam Strirog ,Madan Mohan Malviya Govt. Ayurvedic College, Ambamata, Udaipur Rajasthan,India

Udaipur
RAJASTHAN
313301
India 
Phone  9950129673  
Fax    
Email  narendermeena42@yahoo.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Govt. Ayurved College Udaipur ,Rajasthan 313001, India 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt. Ayurved College Udaipur ,Rajasthan 313001, India 
Address  Madan Mohan Malviya Govt. Ayurved College Rada ji Circle ,Ambamata, Udaipur,313001,Rajasthan ,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 Aditi Jain   Madan Mohan Malviya Govt. Ayurved College Udaipur  OPD no. 05, Prasuti tantra evam striroga department, Rajvaidya Prem Shankar Sharma Rajkeey Ayurveda Chikitsalaya, Ambamata , Udaipur Rajasthan Udaipur, RAJASTHAN opd no 6 prasuti tantra Evum Striroga Department Rajkiya Ayurved Chiktsalaya , motichouchatta,Udaipur ,Rajasthan
Udaipur
RAJASTHAN 		 7339883414

jaditi1203@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee M.M.M Govt Ayurved College Ambamata,Udaipur(Raj)313001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D259||Leiomyoma of uterus, unspecified. Ayurveda Condition: ARBUDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kanchanar Twak Ghana Vati, Reference: Bhavprakash Nighantu Guduchyadivarga/103, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Ashoka Twak Ghana Vati, Reference: Bhavprakash Nighantu Pushpavarga/48, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
3Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak Siddhi Sthana, Procedure details: Matra basti with Darvyadi Kwath Siddha Taila Matra basti 60 ml will be given by rectal route for 7 days(follicular phase) of 3 consecutive menstrual cycle)
(1) Medicine Name: Darvyadi Kwath, Reference: Bhavprakash Madhyama Khand 68/20, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months
4Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak Siddhi Sthana, Procedure details: Matra basti with Darvyadi Kwath Siddha Taila Matra basti 60 ml will be given by rectal route for 7 days(follicular phase) of 3 consecutive menstrual cycle )
(1) Medicine Name: Darvyadi Kwath, Reference: Bhavprakash Madhyama Khand 68/20, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1.Patient who are willing for trial.
2.Single or multiple uterine fibroids of size up to 5 cm.
3.Female patient between age of 25-50 years.
4.The patient either asymptomatic or having clinical signs and symptoms of fibroid 
 
ExclusionCriteria 
Details  1. Patient having bleeding due to abortion or any other pathological condition
2. Patients having coagulation disorders.
3. Pregnant women with fibroid.
4. Patient having any systemic disease like uncontrolled hypertension, diabetes mellitus.
5. Patients with active malignancies.
6. Large size uterine fibroid with pressure symptoms. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in signs and symptoms of uterine fibroid.  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in size of uterine fibroid assessed through USG.  90 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/04/2026 
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 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   Uterine Fibroid is the most common benign tumor of the uterus and is a major cause of menstrual disturbances, pelvic pain, infertility, and hysterectomy in women of reproductive age . From an Ayurvedic perspective ,uterine fibroid can be correlated with Garbhashaya Arbuda ,a condition predominently involving Vata-Kapha dosha with Mamsa, Meda, and Rakta dhatu vitiation.conventional management options are often invasive or hormone dependent, prompting the need for safe ,non invasive alternatives.
this randomized,comparative ,exploratory clinical trial is designed to evalute and compare the efficacy of Ashoka Twak Ghana Vati and Kanchanar  Ghana Vati,each administered along with Darvyadi Kwath Siddha Taila Matra Basti, in the management of Garbhashaya Arbuda with special reference to uterine fibroid.
A total of 60 patients diagnosed with uterine fibroid less than five centimeter will be randomly allocated into two groups of 30 patients each. Group A will receive Ashoka Twak Ghana Vati (500 mg twice daily) along with Darvyadi Kwath Siddha Taila Matra Basti, while Group B will receive Kanchanar Twak Ghana Vati (500 mg twice daily) along with the same Matra Basti regimen. The duration of oral medication will be 90 days, and Matra Basti will be administered for 7 days in the follicular phase for three consecutive menstrual cycles.
The primary outcome measure will be improvement in clinical signs and symptoms of uterine fibroid, including menstrual bleeding pattern, pain, and cycle regularity. The secondary outcome measure will be reduction in the size of fibroid as assessed by ultrasonography. The study aims to generate evidence regarding the comparative effectiveness of these Ayurvedic interventions as conservative, non-surgical management options for uterine fibroid

 
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