| CTRI Number |
CTRI/2024/11/076892 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The Efficacy Of Sarivadi Kwathpan In Yonikandu |
|
Scientific Title of Study
|
A Single Arm Open Label Clinical Study To Evaluate The Efficacy Of Sarivadi Kwath Orally In Yonikandu |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVaidehi Vasantrao Ayalwar |
| Designation |
PG Scholar |
| Affiliation |
Ashtang Ayurved Mahavidyalaya Pune |
| Address |
868, Stree Rog Prasuti Tantra Department Ashtang Ayurved Mahavidya Sadashiv peth Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
8600585080 |
| Fax |
|
| Email |
vayalwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHemalata Jalgaonkar |
| Designation |
HOD |
| Affiliation |
Ashtang Ayurved Mahavidya Pune |
| Address |
868 Stree rog prasuti tantra department Ashtang AYURVED mahavidya Sadashiv peth Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
919881466344 |
| Fax |
|
| Email |
hrj9371@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVaidehi Vasantrao Ayalwar |
| Designation |
PG Scholar |
| Affiliation |
Ashtang Ayurved Mahavidya Pune |
| Address |
868, Stree Rog Prasuti Tantra Department Ashtang Ayurved Mahavidya Sadashiv peth Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
8600585080 |
| Fax |
|
| Email |
vayalwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashtang ayurved mahavidya Sadashiv peth Pune, maharastra 411030 |
|
|
Primary Sponsor
|
| Name |
DrVaidehi Vasantrao Ayalwar |
| Address |
868,stree rog prasuti tantra department Ashtang AYURVED mahavidya Sadashiv peth Pune Maharashtra 411030 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrVaidehi Vasantrao Ayalwar |
Ashtang Ayurved Mahavidyalaya Pune |
Opd no1.868,stree rog prasuti tantra department,Sadashiv peth Pune30
Pune
MAHARASHTRA |
8600585080
vayalwar@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:N909||Noninflammatory disorder of vulvaand perineum, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patint having symptoms of Yonikandu
Controlled blood sugar level |
|
| ExclusionCriteria |
| Details |
Serologically positive patients
Pregnant patients
Patients suffering from auto immune disorder like SLE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Sarivadi Kwath orally On Yonikandu |
Assessment of Sarivadi Kwath orally on Yonikandu for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Sarivadi Kwath orally On Yonikandu |
Assessment of Sarivadi Kwath Orally on Yonikandu for 4 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/11/2024 |
| 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="6"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The current study aimed as assessment of efficiency of Sarivadi Kwath Orally in Yonikandu.Total 50 diagnosed patient will be given the Sarivadi Kwath orally 40ml BD for 3 months .assesment will be done on subjective criteria of Yonikandu |