| CTRI Number |
CTRI/2024/12/078488 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the role of Ayurvedic treatment in prevention of recurrence of abnormal vaginal discharge in reproductive age women: A randomized control trial |
|
Scientific Title of Study
|
To study the role of Ayurvedic treatment in prevention of recurrence of abnormal vaginal discharge in reproductive age women: A randomized control trial |
| Trial Acronym |
VD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Kachhawa |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room number-701, 7th floor,MCH Block, AIIMS , New Delhi-11029
New Delhi
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima kachhawa |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Kachhawa |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
ROOM NUMBER-701, 7TH FLOOR, MCH BLOCK, AIIMS, NEW DELHI
DELHI
110029
India |
| Phone |
9868246702 |
| Fax |
|
| Email |
garimakachhawa2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
ICMR, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Garima Kachhawa |
AIIMS, New Delhi |
Room Number-701, 7th floor, MCH block, AIIMS, New Delhi-110029
New Delhi
DELHI |
09868246702
garimakachhawa2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N761||Subacute and chronic vaginitis. Ayurveda Condition: YONIR, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ayush PVK Gel (Product developed by CCRAS), Reference: Product developed by CCRAS, Route: Vaginal, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 10 Days, Reference: Yes, Route: -, Dosage Form: Kalka/ Paste , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pushyanug churn 3 gm , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: NA, Route: -, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NACO Kit, Reference: standard therapy, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 1 Days, Reference: No, Route: -, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Sexually active women aged 18 to 45 years with complaints of vaginal discharge, itching vulva, burning sensation and foul smell
2. Willing to participate in the study and follow up
|
|
| ExclusionCriteria |
| Details |
1. Women with gross curdy white discharge
2. Pregnant or lactating women
3. Women with severe physical illness or any systemic disease such as DM, any severe hepatic, cardiac, renal disease, any acute infection or chronic corticosteroids use
4. Known HIV infection
5.Any condition on PI discretion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. We expect from this study that the recurrence rate in subjects receiving standard treatment followed by Ayurvedic treatment will be lower than standard treatment alone. |
Follow up at 1, 3, 6, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The study will provide us the side effects & patient acceptability to ayurvedic medicines
2. We will also find out the effect of the ayurvedic medicine on vaginal pH & microflora
|
Follow up at 1, 3, 6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
- Recently various studies have attempted to find new approaches in diet and lifestyle to improve vaginal flora like probiotics and vaginal microbiome transplantation. We propose to explore the role of ayurvedic treatment in standard management of abnormal vaginal discharge in improving remission and decreasing recurrence rates.
- This study will generate new data with greater volume and diversity to provide the effectiveness of ayurvedic medicines in the management of abnormal vaginal discharge. It will also help us know the side-effects and acceptability to this treatment and hence will guide in formulating guidelines for the use of ayurvedic medicines for use.
|