| CTRI Number |
CTRI/2025/03/082448 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the Efficacy of Shatpala Ghrita Uttarbasti and Chitrakmool Churna orally in Garbhashayagata Mamsajgranthi w.s.r. to Uterine Fibroid |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy of Shatpala Ghrita Uttarbasti and Chitrakmool Churna orally in Garbhashayagata Mamsajgranthi 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 Charu Supriya |
| Designation |
Associate Professor |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
ROOM NO. 203 PG Department of Panchkarma RGGPGACH
Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
08894242782 |
| Fax |
|
| Email |
charusupriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Supriya |
| Designation |
Associate Professor |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
ROOM NO. 203 PG Department of Panchkarma RGGPGACH
Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
08894242782 |
| Fax |
|
| Email |
charusupriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arka Ajimal |
| Designation |
PG SCHOLAR |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
Room no. 701 PG Department of Panchkarma RGGPGACH Paprola Teh Baijnath Distt Kangra
176115
H P
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
07018049275 |
| Fax |
|
| Email |
arkaajimal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola Distt Kangra HP
Charak Pharmacy Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital
Paprola District Kangra HP
Research Institute in ISM Jogindernagar District Mandi Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Principal Rajiv Gandhi Govt Post Graduate Ayurvedic CollegePaprolaHimachal Pradesh |
| Address |
Principal cum Dean Room No. 105 Admin Block Rajiv Gandhi
Government Postgraduate Ayurvedic College and Hospital Paprola,Teh Baijnath,Distt Kangra Himachal Pradesh Pincode 176115 INDIA |
| Type of Sponsor |
Government 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 |
| Dr Charu Supriya |
Rajiv Gandhi Ayurvedic College and Hospital |
Room no.203 Reader
Department of
Panchkarma,RGGPG
Ayurvedic College and
Hospital
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
08894242782
charusupriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola District Kangra Himachal Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N73||Other female pelvic inflammatory diseases. Ayurveda Condition: GRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chitrakmool Churna, Reference: Vangsen Granthirog Adhikar 24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - | | 2 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charak Sidhi 9/63-65, Procedure details: Poorvakarma Niruh Basti and Yoni Prakshalan with Triphla Kwath
Pradhan Karma Uttarbasti with Shatpala Ghritta in dose of 5 ml
Pashschat Karma Hot Water Fomentation and Chitrakmool Churna 1 gm bd 2 capsules of 500 mg each for 90 days )
(1) Medicine Name: Chitrakmool Churna, Reference: Vangsen Granthirog Adhikar 24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Duration: 3 Months(2) Medicine Name: Shatpala Ghritta, Reference: Ashtang Hridya Chikitsa Sthan 5/22-23, Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients presenting with clinical diagnosis through Ultrasonography of Fibroid Uterus
Married or sexually active females with age between 20-50 years having Submucosal and Intramural Fibroids of size less than 7 cm. as per USG reports
The patients with Fibroids either asymptomatic or having clinical signs and symptoms of Fibroids (single or multiple) like menometrorhhagia, dysmenorrhoea, weakness etc. will be included in the study.
Patients indicated for Uttarbasti
Patients who will give written consent for the trial
|
|
| ExclusionCriteria |
| Details |
Patients diagnosed on USG and other investigations with Subserous fibroid Pedunculated Fibroid polyps ovarian tumour tubo ovarian mass and malignant tumours
Patients below 20 years of age and above 50 years of age
Menopausal women with fibroids
Patients having Fibroid size more than 7cm
Patients contraindicated for Uttarbasti
Women with Hb less than 7 gm
Uncontrolled hypertension tuberculosis diabetes mellitus and any other severe systemic diseases
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Shodhana and Shamana Chikitsa on Garbhashayagata amsajgranthi wsr Fibroid Uterus
Safety profile of Shatpala Ghrita Uttarbasti and Chitrakmool Churna orally.
quality of life in Uterine Fibroid patients by using Uterine Fibroid Symptoms & Health related Quality of Life Questionnaire (UFS-QOL).
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of Shodhana and Shamana Chikitsa on Garbhashayagata amsajgranthi wsr Fibroid Uterus
Safety profile of Shatpala Ghrita Uttarbasti and Chitrakmool Churna orally.
quality of life in Uterine Fibroid patients by using Uterine Fibroid Symptoms & Health related Quality of Life Questionnaire (UFS-QOL).. |
3 months |
|
|
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)
|
02/06/2025 |
| 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="0"
Months="3"
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
|
I would like to publish my research trial after completion of the trial as soon as possible .Patients will be selected from campus/faculty/OPD of RGGPG Ayurvedic College and Hospital ,Paprola.Two groups of 20 patients each will be assessed on the basis of inclusion and exclusion criteria to know the effect of Uttarbasti and Chitrakmool churna.. |