| CTRI Number |
CTRI/2023/10/058721 [Registered on: 16/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Pathyadi Kwatha In Dysfunctional Uterine Bleeding(Asrigdara) |
|
Scientific Title of Study
|
A CONTROLLED CLINICAL TRIAL TO EVALUATE THE
EFFECT OF PATHYADI KWATHA IN ASRIGDARA W.S.R. TO
DYSFUNCTIONAL UTERINE BLEEDING |
| 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 Komal T Gayakwad |
| Designation |
P G Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka
Bagalkot
KARNATAKA
587315
India |
| Phone |
8088236627 |
| Fax |
|
| Email |
drkomalgayakwad10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P K Rawal |
| Designation |
Professor and HOD |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka
Bagalkot
KARNATAKA
587315
India |
| Phone |
9880976151 |
| Fax |
|
| Email |
chaitanya.rawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal T Gayakwad |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka
Bagalkot
KARNATAKA
587315
India |
| Phone |
8088236627 |
| Fax |
|
| Email |
drkomalgayakwad10@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Post Graduation And Research Centre Terdal |
|
|
Primary Sponsor
|
| Name |
Dr Komal T Gayakwad |
| Address |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Karnataka |
| Type of Sponsor |
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 Komal T Gayakwad |
Padma Ayurvedic Hospital And Research Centre |
SDM Trusts
Ayurvedic Medical College
Danigond Post Graduation Centre
Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Bagalkot
KARNATAKA |
8088236627
drkomalgayakwad10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College and Padma Ayurvedic Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N939||Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi kwatha, Reference: Yogartnakar Uttarardha Stree Roga Nidana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 7 days medication from 4th day to 10th day for two consecutive cycle | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhataki Puga Pushpa Kwatha, Reference: Yogaratnakar Uttarardha Stree Roga Nidana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 7 days medication from 4th day to 10th day of Menses for two Consecutive cycle |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Pratyatma lakshana of Asrigdara and DUB.
Asrigdara-Artava deergha kala Pravritti, Artava Ati Pravritti, Anruta kala Pravritti.
|
|
| ExclusionCriteria |
| Details |
1.K/C/O – Diabetes mellitus, hypertension, tuberculosis.
2.Patient using intra uterine contraceptive device
3.K/C/O-Coagulation disorders
4.Patient with severe anemia HB% below 8 gms
5.K/C/O- Any pelvic pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of trial drug on improvement in the symptoms of Asrigdara(DUB). |
4th day of menses, 10th day for three consecutive cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the trial drug & Adverse Drug reaction & Aggravation in the symptoms of Asrigdara(DUB) |
4th day of menses, 10th day for three consecutive cycle |
|
|
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 |
|
Date of First Enrollment (India)
|
16/10/2023 |
| 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="10"
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
|
- Asrigdara is one among the Raktapradoshaja vikara & is characterized by Artava atipravrutti,Deerghakala pravrutti,Anruta kala pravrutti associated with Angamard and Savedana Artava pravrutti .
- It is similar to Dysfunctional Uterine Bleeding (DUB), characterized by excessive bleeding without any known pelvic pathology
- In this study Pathyadi Kwatha is selected as trial drug for the management of Asrigdara(DUB) and its efficacy is compared with Dhataki-Puga Pushpa Kwatha.
- This is a randomized controlled clinical trial. Total 40 patient of Asrigdara who fulfill the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Asrigdara will be selected
- Total Study duration will be 90 days and contain 6 visits (every 4th and 10th day of 3 comsecutive menstrual cycle), which includes administration of trial drug for 7days for two consecutive cycle and post medication follow up on 4th and 10th day of 3rd menstrual cycle.
- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.
|