| CTRI Number |
CTRI/2024/05/067220 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study The Effect Of Guduchyadi Taila Yonipichu In Yoni Shushkta In Vataj Yonivyapad (In Perimenopausal And Menopausal Women ) |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Efficacy Of Guduchyadi Taila Yonipichu In Yoni Shushkta In Vataj Yonivyapad ( In Perimenopausal And Menopausal Women) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha |
| Designation |
MS Scholar |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre |
| Address |
OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9521015915 |
| Fax |
|
| Email |
drdikshasuthar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Barathe |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9730675211 |
| Fax |
|
| Email |
rahul.barathe@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Barathe |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre |
| Address |
OPD No 2 Department of Stri Roga and Prasuti Tantra Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9730675211 |
| Fax |
|
| Email |
rahul.barathe@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda and Research Centre,Sant Tukaram Nagar,Pimpri,Pune,Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr.Diksha |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Centre ,Sant Tukaram Nagar, Pimpri,Pune, Maharashtra 411018 |
| 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 |
| Dr Diksha |
Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra |
OPD and IPD of Stri Roga avum Prasuti Tantra Department Dr D Y Patil College of Ayurveda and Research Centre,Pimpri,Pune,Maharashtra 411018
Pune
MAHARASHTRA |
9521015915
drdikshasuthar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N958||Other specified menopausal and perimenopausal disorders. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Charak Chikitsa sthan 30, Procedure details: Guduchyadi taila yoni pichu will be given once in a day for five consecutive days)
(1) Medicine Name: Guduchyadi taila, Reference: Charak Chikitsa sthan 30, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women who are suffering with the dryness of vagina,itching,dyspareunia.
Women who are experiencing Perimenopausal and Menopausal phase between the age group 40-60 years.
|
|
| ExclusionCriteria |
| Details |
Women who are in reproductive phase.
Women who are suffering from Uterine prolapse.
Women who are suffering from major illness like carcinoma,TB,HIV-AIDS etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Guduchyadi Taila Yonipichu in Yoni Shushkta in Vataj Yonivyapad (in Perimenopausal and Menopausal women ) |
Yoni Pichu will be given for 5 consecutive days . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of Yonipichu of Guduchyadi Taila in other Rajonirvrutti related problems. |
Yoni Pichu will be given for 5 consecutive days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0" |
|
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 IS A SINGLE ARM CLINICAL STUDY.THE AIM OF THIS STUDY IS TO EVALUATE THE EFFICACY OF GUDUCHYADI TAILA YONIPICHU IN YONISHUSHKTA IN VATAJ YONIVYAPAD ( IN PERIMENOPAUSAL & MENOPAUSAL WOMEN ).
TOTAL 35 PATIENTS WILL BE ENROLLED AND YONI PICHU WILL BE GIVEN FOR 5 CONSECUTIVE DAYS.
THE AGE GROUP TAKEN FOR THE STUDY IS 40 TO 60 YEARS .
SUBJECTIVE AND OBJECTIVE CRITERIA WILL BE STUDIED.
|