| CTRI Number |
CTRI/2024/12/077827 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Curative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of Pathyaputhikadi kashaya and Kankayana gudika in patients with Uterine fibroid |
|
Scientific Title of Study
|
Effect of Pathyaputhikadi kashaya and Kankayana gudika in 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 |
Karthika Dev S |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Pin 682301 Ernakulam KERALA 682301 India |
| Phone |
9446656617 |
| Fax |
|
| Email |
karthikadev.1993@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rajitha R Warriar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Pin 682301 Ernakulam KERALA 682301 India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rajitha R Warriar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda Medical centre |
| Address |
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Pin 682301
Ernakulam KERALA 682301 India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College, Tripunithura, Ernakulam pin 682301 |
|
|
Primary Sponsor
|
| Name |
Karthika Dev S |
| Address |
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam pin 682301 |
| 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 |
| Karthika Dev S |
Government Ayurveda Medical College |
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Pin 682301 Ernakulam KERALA |
9446656617
karthikadev.1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research (Institutional Review Board ), Government Ayurveda Medical centre, Tripunithura, Ernakulam, pin 682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D259||Leiomyoma of uterus, unspecified. Ayurveda Condition: GRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pathyaputhikadi Kashaya , Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Yava kshara, Hingu ), Additional Information: -Kashaya during intermenstrual phase | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kankayana gudika , Reference: Bhaishajya Ratnavali, Gulma chikitsa, 32 nd chapter, 68 th sloga , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: Gudika only during bleeding phase |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Participants of age group 18-45 years with Uterine fibroids, confirmed by USG having complaints of pain and bleeding during menstruation |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Post menopausal women
Hb less than 8 gm%
Fibroid size greater than 8 cm
Degenerative changes in the uterine fibroid confirmed by USG
Known cases of malignancy and genital Tb
Known case of uncontrolled Hypertension, Diabetes mellitus
Known cases of chronic liver and renal disease and coagulation disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in pain and bleeding during menstruation associated with Uterine fibroid |
After 4 th week,8th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in pelvic pain and low back ache associated with Uterine fibroid
To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in reducing the size of the fibroid |
After 1st,2nd and 3rd menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/12/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 fibroids also known as Leiomyomas, are smooth tumors of the These are more common in nulliparous or in those having one child infertility. Symptoms include abnormal uterine bleeding, dysmenorrhoea, pelvic pressure, bowel dysfunction , urinary frequency and urgency, urinary retention, low back pain, constipation and dyspareunia. There is no direct reference for uterine fibroid in Ayurveda. The treatments explained in the context of Gulma and Sula can be taken for the management of uterine fibroid. Pathyaputhikadi kashaya is mentioned in Sahasrayogam with an indication of Arsa, Gulma, Ashteela, Anaha , Sula etc and Kankayana gudika is mentioned in Bhaishajya Ratnavali with an indication of Gulma,Arsa etc are taken for the study. The study design is an interventional pre and post study, with a sample size of 26. Subjects aged 18 -45 years, diagnosed with Uterine fibroid having pain and bleeding following the inclusion and exclusion criteria will be taken for the study. Data collection will be done by clinical observation through case proforma and relevant investigations will also be done. The medicine will be administered on the following basis. 48 ml of Pathyaputhikadi kashaya before food during intermenstrual phase and 2 tablets (600 mg) of Kankayana gudika with 50 ml milk after food during the bleeding phase, twice daily for 3 consecutive menstrual cycle. The patient will be assessed at the end of each menstrual cycle. Menstrual bleeding is assessed by the Pictorial Blood Loss Assesment Chart (PBAC scale) and pain during menstruation, low back ache, pelvic pressure is assessed by Visual Analogue scale ( VAS). The size of the fibroid is assessed by USG before treatment and after treatment. The data collected will be statistically analysed through appropriate tests and a conclusion will be drawn. |