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CTRI Number  CTRI/2026/02/103898 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 16/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   A clinical study on herbal oil enema therapy for heavy menstrual bleeding. 
Scientific Title of Study   An interventional clinical study to evaluate the efficacy of matra vasti with tiktaka ghritam in asrigdara (thtckened endometrtum) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrLeela Ramakrishnan 
Designation  Associate Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College & Hospital Banalore Chennai Highway Nazrathpet,Chennai 
Address  Room No 13 PG DEPARTMENT OF PRASUTI TANTRA AND STRI ROGA SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL NAZARATHPET CHENNAI -

Kancheepuram
TAMIL NADU
600123
India 
Phone  9942360360  
Fax    
Email  drleelaa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrLeela Ramakrishnan 
Designation  Associate Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College & Hospital Banalore Chennai Highway Nazrathpet,Chennai 
Address  Room No 13 PG DEPARTMENT OF PRASUTI TANTRA AND STRI ROGA SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL CHENNAI

Kancheepuram
TAMIL NADU
600123
India 
Phone  9942360360  
Fax    
Email  drleelaa@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrLeela Ramakrishnan 
Designation  Associate Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College & Hospital Banalore Chennai Highway Nazrathpet,Chennai 
Address  Room No 13 PG DEPARTMENT OF PRASUTI TANTRA EVAM STRI ROGA SRI JAYENDRA SARASWATHI AYURVEDA COLLEGE AND HOSPITAL

Kancheepuram
TAMIL NADU
600123
India 
Phone  9942360360  
Fax    
Email  drleelaa@gmail.com  
 
Source of Monetary or Material Support  
sri Jayendra Saraswathi Ayurveda college and Hospital 
 
Primary Sponsor  
Name  DrLeela Ramakrishnan 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai 600123 Dept. of Ayurveda of SCSVMV(Deemed to be University) Enathur Kanchipuram - 631561 
Type of Sponsor  Private 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 
DrLeela Ramakrishnan  Sri Jayendra Saraswathi Ayurveda College and Hospital   Room No 13 PG Department of Prasuti Tantra and Stri Roga Nazarathpet chennai
Kancheepuram
TAMIL NADU 		 09942360360

drleelaa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Jayendra Saraswathi Ayurveda College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  with Heavy menstrual bleeding 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka Samhita, Procedure details: Matra vasti 72ml with Tiktakam Ghritam through anal route.)
(1) Medicine Name: Tiktakam GHritam, Reference: Ashtanga Hridaya, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Endometrial thickness more than 10mm.
Age 45 to 55
Heavy menstrual bleeding
TVS ultrasound suggestive of thick endometrium
willing to participate and give written informed consent 
 
ExclusionCriteria 
Details  Hormonal therapy use in last 3 months
OCPs
Progesterone
HRT
Tamoxifen
Diagnosed endometrial pathology
Endometrial polyp
Submucous fibroid
Endometrial atypical hyperplasia
Hypothyroidism
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the duration of the menstrual bleeding recorded by menstrual diary at the baseline and after 12 weeks  Reduction in the endometrial thickness measured using TVS ultrasound after 12 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   27/02/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report
    Response (Others) -  nil
  3. Who will be able to view these files?
    Response (Others) -  nil

  4. For what types of analyses will this data be available?
    Response (Others) -  nil

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 14-02-2026 and end date provided 14-02-2027?
    Response (Others) -  nil

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information -  nil
Brief Summary   This interventional single arm open label clinical study is planned to evaluate the efficacy of Matra Vasti with Tiktaka Ghritam in women diagnosed with Asrigdara correlated with thickened endometrium on ultrasonography. Thickened endometrium is commonly associated with abnormal uterine bleeding prolonged menstruation and hormonal imbalance which closely resemble the features of Asrigdara described in Ayurveda. In this study eligible women will receive Matra Vasti with Tiktaka Ghritam for a specified duration. The effect of the intervention will be assessed by measuring changes in endometrial thickness by ultrasonography menstrual bleeding pattern and associated symptoms before and after treatment. The primary out come will be reduction in endometrial thickness measured by ultrasonography. Secondary outcomes include improvement in duration and amount of menstrual bleeding and relief in associated symptoms of Asrigdara. The study aims to generate clinical evidence for the role of Matra Vasti with Tiktaka Ghritam in managing thickened endometrium through an Ayurvedic approach. 


 
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