| CTRI Number |
CTRI/2022/10/046598 [Registered on: 18/10/2022] Trial Registered Prospectively |
| Last Modified On: |
04/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Panchtikta Gandhak Guggulu With Panchvalkala Siddha Sneha Yoni Pichu On Vaginal White Discharge |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Panchtikta Gandhak Guggulu With Panchvalkala Siddha Sneha Yoni Pichu On Upapluta Yoni Vyapada W.S.R. To Candidial Vulvovaginitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sulekha |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Govt Ayurved College Udaipur |
| Address |
PG Department Of Prasuti Tantra Evam Stri Roga Madan Mohan Malviya Govt Ayurved College Campus Ambamata
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587169705 |
| Fax |
|
| Email |
sulekhachoudhary1697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mahesh Dixit |
| Designation |
Principal & Guide |
| Affiliation |
Madan Mohan Malviya Govt Ayurved College Udaipur |
| Address |
PG Department Of Prasuti Tantra Evam Stri Roga Madan Mohan Malviya Govt Ayurved College Campus Ambamata
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414245459 |
| Fax |
|
| Email |
prof.maheshdixit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mahesh Dixit |
| Designation |
Principal & Guide |
| Affiliation |
Madan Mohan Malviya Govt Ayurved College Udaipur |
| Address |
PG Department Of Prasuti Tantra Evam Stri Roga Madan Mohan Malviya Govt Ayurved College Campus Ambamata
RAJASTHAN
313001
India |
| Phone |
9414245459 |
| Fax |
|
| Email |
prof.maheshdixit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt Ayurved College Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Govt Ayurved College Ambatmata Udaipur |
| 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 |
| Prof Mahesh Dixit |
Madan Mohan Malviya Govt Ayurved College Udaipur |
OPD Room No. 5 PG Department Of Prasuti Tantra Evam Stri Roga And All Associate Hospital Of Madan Mohan Malviya Govt Ayurved College
Udaipur
RAJASTHAN |
9414245459
prof.maheshdixit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: Patients With Excessive Vaginal White Discharge, (2) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Yoni Pichu | (Procedure Reference: Ashtang Sanghrah Uttarsthan 39/49, Procedure details: Panchvalkala Siddha Sneha Yoni Pichu Per Vaginal Dose 5ml once In A Day For Alternate Week For Three Month)
(1) Medicine Name: Panchvalkala Siddha Sneha Yoni Pichu, Reference: Ashtang Sanghrag Uttarsthan 39/49, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Months | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Panchtikta Gandhak Guggulu, Reference: NA, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Ushan jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients Willing For Trail
2.Patients age more than 18 year who are sexually active or reproductively active with complaints of genital pruritus and or discharge per vagina
3.Pap smear positive for Candida |
|
| ExclusionCriteria |
| Details |
1.Patients age less than 18 year
2.patients suffering from chronic systemic diseases as hypertension and cardiac disease
3.Pap smear negative for Candida infection |
|
|
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 |
| Improvement in the signs and symptoms from the treatment in the patients |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of treatment |
15 Days follow Up For 3 Months |
|
|
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)
|
15/11/2022 |
| 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
|
Nil |
|
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 Panchtikta Gandhak Gugguku with Panchvalkala Siddha Sneha Yoni Pichu on Upapluta Yoni Vyapada W.S.R. Candidial Vulvovaginitis. This is single arm study so all 30 patients will be treated with Panchvalkala Gandhak Guggulu orally 500mg twice a day with ushan jal and Panchvalkala Siddha Sneha Yoni Pichu applied vaginally 5ml once a day. Trail will be carried upto three consecutive months. |