| CTRI Number |
CTRI/2023/08/056850 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Phala Ghrita and Panchvalkaladi Kwath Yoni Prakshlana on Vulvovagnitis |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of phala ghrita and panchvalkaladi Kwath Yoni Prakshalana on pittaja yonivyapad w.s.r to vulvovagnitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal Shinde |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
P.G.Department of Prasuti Tantra Evam Stree Roga
Madan Mohan Malviya Government Ayurved College
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9727719125 |
| Fax |
|
| Email |
komalshinde59291@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNarendra Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
O.P.D No.-5
Prasuti Tantra Evam Stree Roga
Madan Mohan Malviya Government Ayurved College
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNarendra Kumar Meena |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
O.P.D No.-5
Prasuti Tantra Evam Stree Roga
Madan Mohan Malviya Government Ayurved College
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Radaji circle Ambamata Udaipur 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 Narendra Kumar Meena |
Madan Mohan Malviya Government Ayurved College Udaipur |
O.P.D.Room no.5,P.G.Dept. of Prasuti Tantra and Stree Roga,Madan Mohan Malviya Government Ayurved College Udaipur
Udaipur
RAJASTHAN
Udaipur
RAJASTHAN |
9950129673
narendermeena42@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE M.M.M Govt. Ayurved College Ambamata,Udaipur (Raj.) 313001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: PITTAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Phala Ghrita, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Dugdh), Additional Information: -(2) Medicine Name: Panchvalkaladi Kwath Yoni Prakshalana, Reference: Charak Samhita, Route: Vaginal, Dosage Form: Kwatha/ Kashaya, Dose: 150(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Panchvalkaladi Yoni Prakshalana for 5 days at interval of 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
INCLUSION CRITERIA:
1. Patients willing for trial.
2. Patients aged more than 18 years to 40 years of age who are sexually or reproductively active.
3. Patients presenting with symptoms of yoni strava (abnormal vaginal discharge)
yoni daha (vaginal burning), yoni paka (vaginal suppuration) |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA-
1. Patient not willing for trial
2. Pregnant Women’s.
3. H/O diabetes mellitus, hypertension, asthma.
4. Reproductive malignancies.
5. Endometriosis/chocolate cyst, pelvic abscess
6. Severe or chronic ill health conditions.
7. Patient positive for HIV, HBsAG, VDRL
8. Patient associated with tubercular infections
9. Patient with exclusively bartholinitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will look for improvement in symptoms like Yoni Strava,Yoni Daha & Yoni Paka |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
we will look for improvement in symptoms of Vulvovagnitis
|
15 days,30 days & 45 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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2023 |
| 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="1"
Days="15" |
|
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 about evaluating the efficacy of Phala Ghrita and Panchvalkaladi Kwath Yoni Prakshalana on management of Pittaja Yonivyapad w.s.r to Vulvovagnitis.This is single arm study,so all the 30 Patients will be given Phala Ghrita 10ml once a day orally with dugdh with Panchwalkaladi kwath Yoni Prakshalana for 5 days at interval of 15 days |