| CTRI Number |
CTRI/2025/07/090612 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| 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 Jambwadi Kashaya over Vasadi Kashaya in Raktapradara (Dysfunctional Uterine Bleeding) |
|
Scientific Title of Study
|
A Controlled Comparative Clinical Trial to Evaluate the Efficacy of Jambwadi Kashaya over Vasadi Kashaya in the Management of Raktapradara(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 Soumya Benachanamardi |
| Designation |
PG Scholar |
| Affiliation |
SDMTs Ayurvedic College and Hospital Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SHIDDHANT NAGAR TERDAL 587315 BAGALKOT KARNATAKA
Bagalkot
KARNATAKA
587315
India |
| Phone |
7483751466 |
| Fax |
|
| Email |
soumya281099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parashuram K Rawal |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
SDMTs ayurvedic college and hospital terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SHIDDHANT NAGAR TERDAL 587315 BAGALKOT KARNATAKA
Bagalkot
KARNATAKA
587315
India |
| Phone |
9880976151 |
| Fax |
|
| Email |
Chaitanya.rawal5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya Benachanamardi |
| Designation |
PG Scholar |
| Affiliation |
SDMTs ayurvedic college and hospital terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SHIDDHANT NAGAR TERDAL 587315 BAGALKOT KARNATAKA
Bagalkot
KARNATAKA
587315
India |
| Phone |
7483751466 |
| Fax |
|
| Email |
soumya281099@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Post Graduation Centre and Padma Hospital Terdal 587315 Bagalkot Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Soumya Benachanamardi |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SHIDDHANT NAGAR TERDAL 587315 BAGALKOT 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 Soumya Benachanamardi |
SDMTs Ayurvedic College and Hospital Terdal |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SHIDDHANT NAGAR TERDAL 587315 BAGALKOT KARNATAKA
Bagalkot
KARNATAKA |
07483751466
soumya281099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTAMC Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasadi Kashaya, Reference: Sahasrayoga , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Sita and Ghruta), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jambwadi Kashaya, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Sita and Ghruta), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients of age group 16 - 40 years
2.Patients with excessive and prolonged bleeding p/v during menstruation
3.Patient willing to sign Consent form |
|
| ExclusionCriteria |
| Details |
1.Hb% below 8gms
2.Patient using Intra uterine contraceptive devices
3.Known cases of Hypertension, Diabetes mellitus, Malignancy, Tuberculosis or any uncontrolled severe systematic disorders and metabolic disorders
4.Known cases of Coagulation disorders
5.Known cases of any pelvic pathology (e.g.Uterine fibroid, Pelvic inflammatory disease)
6.Any other illness reseacher feels that interfere the inyervention of the study |
|
|
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 of classical symptoms of Raktapradara (Dysfunctional Uterine Bleeding) |
5 Days - Starting fron 5th day of menstruation for 5 days X 2 consecutive cycles
Follow up - 10th of Menstruation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the Trial drug and adverse drug reaction and aggravation in symptoms of Raktapradara(Dysfunctional Uterine Bleeding) |
5 Days - Starting fron 5th day of menstruation for 5 days X 2 consecutive cycles
Follow up - 10th of Menstruation |
|
|
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)
|
16/07/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Raktapradara has been mentioned one among Rakta pradoshaja vikara. It is mentioned in ayurveda that vitiated vata withholding rakta increases in their amount and reaches rajavaha srotas and increases raja. The excessive flow of raja from yoni is known as Raktapradara. Clinical features of Raktapradara includes atiarthava pravrutti, deergakala arthava pravrutti associated with savedana arthava pravrutti and anga marda. Raktapradara can be corelated with Dysfunctional Uterine Bleeding explained in modern science. DUB is a state of abnormal uterine bleeding without any clinically detectable organic, systemic and iatrogenic cause(PID, Pregnancy etc excluded). Objectives of the study is to evaluate the effect of Jambwadi Kashaya in the management of Raktapradara (DUB). This is the randomized comparative clinical study. Total 40 patients of Raktapradara are selected and randomly devided into 2 groups. Group A given Jambwadi Kashaya and Group B given Vasadi Kashaya. The subjective and objective parameters are selected for assessment. Total study duration is 3 Menstrual Cycles and includes 3 visits. After study data will be collected from case report form and statistically analysed by using appropriate parametric and non parametric tests and result will be obtained. On the basis of result conclusion will be drawn. |