| CTRI Number |
CTRI/2026/02/103984 [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 study to evaluate the effect of herbal enema therapy in the management of Adenomyosis. |
|
Scientific Title of Study
|
An interventional study to evaluate the effect of Mustadi Yapana
Vasti in the management of 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 |
DrLeela Ramakrishnan |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda Medical College and Hospital |
| Address |
Room No 13
PG Department of Prasuti Tantra and Stri Roga Nazarathpet Chennai 600123
Kancheepuram
TAMIL NADU
600123
India |
| Phone |
09942360360 |
| Fax |
|
| Email |
drleelaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrLeela Ramakrishnan |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda Medical College and Hospital |
| Address |
Room No 13
PG Department of Prasuti Tantra and Stri Roga
Nazarathpet Chennai 600123
Kancheepuram
TAMIL NADU
600123
India |
| Phone |
09942360360 |
| Fax |
|
| Email |
drleelaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrLeela Ramakrishnan |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda Medical College and Hospital |
| Address |
Room No 13
PG Department of Prasuti Tantra and Stri Roga
Nazarathpet Chennai 600123
Kancheepuram
TAMIL NADU
600123
India |
| Phone |
09942360360 |
| Fax |
|
| Email |
drleelaa@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrLeela Ramakrishnan |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet Chennai 600123 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
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 600123
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Painful menstruation |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Mustadi Yapana vasti Pradhan Karma | (Procedure Reference: Charaka samhita, Procedure details: Mustadi Yapana vasti 450 ML once in a day for five days )
(1) Medicine Name: Mustadi kashaya, Reference: Charaka samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 450(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Age group between 35 to 50 years
Diagnosed case of Adenomyosis
Dysmenorrhea
Willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Use of IUD
Co morbid - Diabetes, Hypertension, cardiac disease
Polyps, uterine fibroid, malignancy, Coagulopathy, Ovulatory function, Endometrial, Iatrogenic, Endocrine disease [ Hypo/ Hyper Thyroids], non-menstrual causes for bleeding [ foreign body, abortion] |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in menstrual blood loss measured by pictorial blood loss asessment chart (PBAC) score from baseline to 12 weeks after intervention. |
Reduction in uterine volume measured by ultrasonography at baseline and after 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
il |
|
|
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 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
Response (Others) - nil
- Who will be able to view these files?
Response (Others) - nil
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 02-01-2027 and end date provided 02-01-2027?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
To assess the efficacy of Mustadi
Yapana Vasti in Adenomyosis. To evaluate changes
in myometrium [ USG- TVS] after Mustadi
Yapana Vasti in women
diagnosed with Asrigdara and
documented as Adenomyosis. To assess clinical improvement in
menstrual bleeding [quantified by PBAC score]
To assess clinical improvement in
dysmenorrhoea
To measure changes in haemoglobin
|