| CTRI Number |
CTRI/2026/02/102780 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurvedic Enema Therapy and Herbal Tablets in Women with Uterine Fibroids. |
|
Scientific Title of Study
|
To Evaluate The Combined Efficacy of Triphala Lekhana Basti And Kanchanara Guggulu Orally in Uterine Fibroids A Single Arm Clinical 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 |
Dr Geetashree |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi KARNATAKA 574118 India
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
Udupi
KARNATAKA
574118
India |
| Phone |
9113688900 |
| Fax |
|
| Email |
pgeetashree0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpana Jain |
| Designation |
Assistant professor M.S(Ayu) |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
| Address |
Department of Prasuti tantra evum streeroga Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi Karnataka 574118 India
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
Udupi
KARNATAKA
574118
India |
| Phone |
9880288577 |
| Fax |
|
| Email |
arpanajainsdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetashree |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
Udupi
KARNATAKA
574118
India |
| Phone |
9113688900 |
| Fax |
|
| Email |
pgeetashree0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Geetashree Pg Scholar Department of Prasootitantra Evum Streeroga Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Udupi 574118 |
|
|
Primary Sponsor
|
| Name |
Dr Geetashree |
| Address |
Department of prasuti tantra and stree roga sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Udupi 574118 |
| Type of Sponsor |
Other [Other(self)] |
|
|
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 |
| Dr Geetashree |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Udupi |
Department of Pg and Phd studies in Prasutitantra Evum Streeroga OPD and IPD
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady udupi
Udupi
KARNATAKA |
9113688900
pgeetashree0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE HUMAN SDMCAU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D251||Intramural leiomyoma of uterus. Ayurveda Condition: MAMSAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kanchanara guggulu, Reference: sharangadhara samhita madhyama khanda and bhaishajya ratnavali Arbuda chikitsa, Route: Oral, Dosage Form: Guggulu , Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 81 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Subjects fulfilling the diagnostic criteria
Women aged between 20-45 yrs
Married and unmarried women
Subjects fit for Lekhana basti |
|
| ExclusionCriteria |
| Details |
Hb less than 9gm%
Patients with heavy menstrual bleeding
Pedunculated Fibroid
Subjects under hormonal therapy
Pregnant and lactating women
Systemic diseases intervening the treatment
Malignant conditions
Postmenopausal women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
patients will be assessed on the basis of Subjective & Objective parameters.
SUBJECTIVE PARAMETERS-
Dysmenorrhea
Menstrual bleeding pattern
Pelvic pain
Constipation
Increased frequency of micturition
Dyspareunia
OBJECTIVE PARAMETERS:
Number of fibroids
Size and location of fibroids
Uterine size
Endometrium thickness |
90 days treatment and 1 month followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in pressure symptoms
Regularization of menstrual cycle
Changes in uterine size |
90 days treatment and 1 month followup |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/02/2026 |
| 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="2"
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
|
This is an open labelled single arm clinical study To evaluate the efficacy of Triphala lekhana basti and Kanchanara guggulu orally in uterine fibroids A total of 20 patients will be administered Triphala kashaya niruha basti will be administered in the dosage of 600ml in Kalabasti course wherein 6 triphala kashaya niruha basti will be administered on 2nd to 7th day in the morning empty stomach and Anuvasana in the afternoon after lunch. Two Anuvasana basti with
Panchatiktaka ghrita+ tila taila in the dose of 40ml each will be administered on 1st and 8th day in the morning and afternoon immediately after food and Kanchanara guggulu will be administered orally 1.5gm from 9th day to 90th day of treatment followed by a followup period of 1 month
The study will be conducted in Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi The
primary outcome measures will be assessed by subjective and objective parameters |