| CTRI Number |
CTRI/2025/06/089161 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Amalki Churna and Saraladi Yoni Dhupan in Shwet Pradara (Bacterial Vaginosis). |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Amalaki Churna and Saraladi Yoni Dhupan on Shwet Pradara w.s.r to Bacterial Vaginosis. |
| 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 Priyanka Mall |
| Designation |
PG Scholar |
| Affiliation |
MMM Government Ayurved College |
| Address |
PG Department of Prasuti Tantra Evam Strirog MMM Government Ayurved College ,Amba Mata ,Udaipur ,Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9588237283 |
| Fax |
|
| Email |
priyankagurjar3006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor and Guide |
| Affiliation |
MMM Government Ayurved College |
| Address |
PG Department of Prasuti Tantra Evam Strirog MMM Government Ayurved College ,Amba Mata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor and Guide |
| Affiliation |
MMM Government Ayurved College |
| Address |
PG Department of Prasuti Tantra Evam Strirog MMM Government Ayurved College ,Amba Mata,Udaipur,Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MMM Government Ayurved College,Rada ji Chauraha,Amba Mata,Udaipur,Rajasthan (India) Pin -313001 |
|
|
Primary Sponsor
|
| Name |
MMM Government Ayurved College |
| Address |
MMM Government Ayurved College ,Amba Mata, Udaipur,Rajasthan,313001 |
| 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 Priyanka Mall |
MMM Government Ayurved College |
OPD no -5,Prasuti Tantra Evum Striroga Department,Udaipur Rajasthan,313001
Udaipur
RAJASTHAN |
9588237283
priyankagurjar3006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE MMM GOVERNMENT AYURVED COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: Charak Chikitsa 30/120, Procedure details: After cessation of menses for 7 days Saraladi Yoni Dhupan is provided externally ,10 gm in one sitting per day.)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki Churna, Reference: Charak Chikitsa 30/119, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
The patients having clinical sign and symptoms of Shwet Pradara (Bacterial Vaginosis). |
|
| ExclusionCriteria |
| Details |
Pregnant women,Patients suffering from Tuberculosis,Sexually transmitted Diseases like HIV, Gonorrhoea,Genital Melignancy. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms and signs of Shwet Pradara with special references to Bacterial Vaginosis. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To cure shwet pradara with special references to Bacterial Vaginosis with changes in associated symptoms like burning, pain, itching and low backache. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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
|
THIS STUDY IS A CLINICAL STUDY TO EVALUATE THE EFFICACY OF AMALAKI CHURNA AND SARALADI YONIDHUPAN ON SHWET PRADARA W.S.R. TO BACTERIAL VAGINOSIS. THERE WILL BE 1 GROUP IN THE SUDY, PATIENT WILL BE SELECTED RANDOMLY AND CLINICALLY DIAGNOSED 30 PATIENT OF SHWET PRADARA BACTERIAL VAGINOSIS. TRIAL WILL BE CONDUCTED FOR A PERIOD OF 3 MONTH. FOLLOW UP OF THE CASE WILL BE DONE AFTER COMPLETION OF 15 DAYS. |