| CTRI Number |
CTRI/2025/04/085982 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate The Efficacy Of Mudgapushpadi Kwath Yonidhawan In Kaphaj Yonivyapad
|
|
Scientific Title of Study
|
A Single Arm Open Label Clinical Study To Evaluate The Efficacy Of Mudgapushpadi Kwath Yonidhawan In Kaphaj Yonivyapad |
| 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 Varsha Panjabrao Siram |
| Designation |
Pg Scholer |
| Affiliation |
Ashtang Ayurved Mahavidyalaya Pune |
| Address |
868 Streerog and Prasutitantra Department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Maharashtra
411030
India
Pune
MAHARASHTRA
411030
India |
| Phone |
9527044047 |
| Fax |
|
| Email |
varshasiram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemalata Jalgaonkar |
| Designation |
HOD |
| Affiliation |
Ashtang Ayurved Mahavidyalaya Pune |
| Address |
868 Streerog and Prasutitantra Department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Maharashtra
411030
India
Pune
MAHARASHTRA
411030
India |
| Phone |
919881466344 |
| Fax |
|
| Email |
hrj9371@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Panjabrao Siram |
| Designation |
Pg Scholer |
| Affiliation |
Ashtang Ayurved Mahavidyalaya Pune |
| Address |
868 Streerog and Prasutitantra Department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Maharashtra
411030
India
Pune
MAHARASHTRA
411030
India |
| Phone |
9527044047 |
| Fax |
|
| Email |
varshasiram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune Maharashtra 411030 |
|
|
Primary Sponsor
|
| Name |
Dr Varsha Panjabrao Siram |
| Address |
868 Streerog and Prasutitantra Department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Maharashtra
411030
India |
| Type of Sponsor |
Other [] |
|
|
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 Varsha Siram |
Ashtang Ayurved Mahavidyalaya |
868 Stree Rog And Prasuti Tantra Department Ashtang Ayurved Mahavidyalaya Sadashivpeth Pune
Pune
MAHARASHTRA |
9527044047
varshasiram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMETTE DECISION FORUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mudgapushpadi Kwath , Reference: Yogratnakar, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 1000(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Yonigat picchail srav
Yonigat vedana
Yonigat gandha
Atishithil yoni |
|
| ExclusionCriteria |
| Details |
K/c/o HIV Tuberculosis and other sexually transmitted disease
Cervical and uterine malignancy
Pregnent women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy Of Mudgapushpadi Kwath Yonidhawan In Kaphaj Yonivyapad |
In 7 days of treatment 2 assessment will be done before treatment and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy Of Mudgapushpadi Kwath Yonidhawan In Kaphaj Yonivyapad |
To Evaluate The Efficacy Of Mudgapushpadi Kwath Yonidhawan In Kaphaj Yonivyapad after 7 days of treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2025 |
| 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
|
The current study aimed as assessment of efficacy of Mudgapushpadi Kwath Yonidhawan In Kaphaj Yonivyapad.Total 60 patient will be given Mudgapushpadi Kwath Yonidhawan for 7 Assessment will be done by observing the symptoms of Kaphaj Yonivyapad |