| CTRI Number |
CTRI/2021/03/032120 [Registered on: 18/03/2021] Trial Registered Prospectively |
| Last Modified On: |
11/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Clinical study to see the effect of some Ayurvedic formulation in patients of itching in vulva |
|
Scientific Title of Study
|
A Comparative Clinical study To evaluate the effect of Guduchidantyadi Vati & Guduchidantyadi Malahar in Acharana Yonivyapad WSR to Pruritus Vulvae |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ekta Dubey |
| Designation |
MD Ayurveda research scholar |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
PG Department of Prasuti tantra and Stri Roga OPD State Ayurvedic College and Hospital Tulsidas Marg Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8573801803 |
| Fax |
|
| Email |
ektadubey.0110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma Devi |
| Designation |
Lecturer PG Department of Prasuti Tantra and stri roga |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
PG Department of Prasuti tantra and Stri Roga OPD State Ayurvedic College and Hospital Tulsidas Marg Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8115421178 |
| Fax |
|
| Email |
dr.reshma1411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ekta Dubey |
| Designation |
MD Ayurveda research scholar |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
PG Department of Prasuti tantra and Stri Roga OPD State Ayurvedic College and Hospital Tulsidas Marg Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8573801803 |
| Fax |
|
| Email |
ektadubey.0110@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital Lucknow |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital lucknow |
| Address |
State Ayurvedic College and Hospital Tulsidas Marg lucknow |
| 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 Ekta Dubey |
State Ayurvedic College and Hospital Lucknow |
PG department of Prasuti Tantra and Stri Roga OPD State Ayurvedic College and Hospital Tulsidas Marg Lucknow
Lucknow
UTTAR PRADESH |
8573801803
ektadubey.0110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe State Ayurvedic College and Hospital Lucknow |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE STATE AYURVEDIC COLLEGE AND HOSPITAL LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH योनिरोगः/योनि-वà¥à¤¯à¤¾à¤ªà¤¦à¤ƒ, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchidantyadi Malahar |
Group 2
Dose-3gm thrice a day as local application for 21 days. |
| Intervention |
Guduchidantyadi Vati |
Group 1
Dose-2 vati (500mg)thrice a day for 21 days. |
| Comparator Agent |
Guduchidantyadi Vati & Guduchidantyadi Malahar |
Guduchidantyadi Vati oral administration thrice a day and Guduchidantyadi Malahar local application thrice a day for 21 days . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients willing to participate in trial
Adult Female who are in age group of 18-45 years
Only married patient
Patients having pruritus vulvae as a cardinal symptom with or without vaginal discharge |
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 45 years
Patients unwilling too participate in the trial Patients after menopause.
Patients who are willing to conceive.
Patients of uterine prolapse and Ca-cervix.
Patients on oral contraceptives or using intra uterine contraceptive device.
Patients with diabetes mellitus, tuberculosis,
severe hypertension, jaundice.
Patients with chronic cervicitis, fibroid and malignancy.
VDRL, HIV, HBsAg positive patient.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of oral administration of Guduchidantyadi Vati and Guduchidantyadi Malahar in Pruritus vulvae
|
Trial will be conducted for 1 month ( 21 days with medicine and 7 days without medicine) .Patient will be followed once a week during treatment and 7 days after the treatment is completed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of trial drug on subjective parameters white discharge p/v, malodor, vulvar pain , coital frequency , dyspareunia , burning micturition & inflammation in vulva |
1 month |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/03/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The finding of the study will be published in indexed and peer reviewed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type of study-Randomized comparative parallel open clinical trial, to evaluate and compare the effect of Guduchidantydi Vati and Guduchidantyadi Malahar in Acharana yonivyapada( pruritus vulvae). 40 patients in the age group of 18 to 45 years will be registered randomly from OPD and IPD of PG department of Prasuti tanta and Stri roga State Ayurvedic College and Hospital Lucknow after taking permission from Institutional Ethics committee and consent from the patient. Patients will be allocated in group A and Group B of 20 patients each. Group A-Guduchidantyadi Vati will be administrated orally for 21 days Group B- Guduchidantyadi Malahar local application for 21 days.
|