| CTRI Number |
CTRI/2024/01/061928 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Single Arm Clinical Study To Evaluate The Effect Of Hingvadi Gutika In Udavarta Yonivyapada |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study To Evaluate The Effect Of Hingvadi Gutika In Udavarta Yonivyapada |
| 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 Prachie Sanjog Pardeshi |
| Designation |
MS Scholar Stree Rog And Prasuti Tantra |
| Affiliation |
SSAM hadapsar pune |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi Hadapsar,Pune.OPD No. 12, Department Of Prasuti Tantra And Stree Rog, Sane Guruji Arogya Kendra , Hadapsar,Pune .
Pune
MAHARASHTRA
411028
India |
| Phone |
8999822065 |
| Fax |
|
| Email |
pardeshiprachie30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana B Ayare |
| Designation |
Associate Professor Department Of Prasuti Tantra And Stree Rog |
| Affiliation |
Sumatibhai saha Ayurveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi Hadapsar,Pune.OPD No. 12, Department Of Prasuti Tantra And Stree Rog, Sane Guruji Arogya Kendra , Hadapsar,Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9423295630 |
| Fax |
|
| Email |
drkalpanaayare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana B Ayare |
| Designation |
Associate Professor Department Of Prasuti Tantra And Stree Rog |
| Affiliation |
Sumatibhai saha Ayurveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi Hadapsar,Pune.OPD No. 12, Department Of Prasuti Tantra And Stree Rog, Sane Guruji Arogya Kendra , Hadapsar,Pune .
MAHARASHTRA
411028
India |
| Phone |
9423295630 |
| Fax |
|
| Email |
drkalpanaayare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi Hadapsar,Pune.OPD No. 12, Department Of Prasuti Tantra And Stree Rog, Sane Guruji Arogya Kendra , Hadapsar,Pune-411028 |
|
|
Primary Sponsor
|
| Name |
SANE GURUJI AROGYA KENDRA |
| Address |
SANE GURUJI AROGYA KENDRA ,MALWADI, HADAPSAR ,PUNE 411028. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prachi Sanjog Pardeshi |
Sane Guruji Arogya Kendra |
OPD 12 ,Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi Hadapsar,Pune.OPD No. 12, Department Of Prasuti Tantra And Stree Rog, Sane Guruji Arogya Kendra , Hadapsar,Pune-411028
Pune
MAHARASHTRA |
8999822065
pardeshiprachie30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hingvadi Gutika , Reference: Sahastra yog, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient suffering from udavarta Yoni Vyapada
2. Married or unmarried patient of age group 20 to30 yrs
3. Patient having pain during Menstruation
4. Patient having painful menses as compared to previous menses
5. Patient ready for clinical trial |
|
| ExclusionCriteria |
| Details |
Hypothyroidism, HIV, HbsAg, VDRL, prolactaemia, tuberculosis,utrine fibroid,complex ovarian cyst, dermoid cyst, tubo-ovarian mass, cervical polyp or growth.
5 Patients suffering from uterine synechiae, endometriosis or malignancy.
6 Pregnancy lactating and post natal female. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Hingvadi Gutika 250 mg BD orally in Udavarta Yonivyapada |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Literature study of Udavarta Yonivyapada.
Preparation of Hingvadi Gutika
To Observe adverse effect if any of Hingvadi Gutika . |
18 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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 AN OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFECT OF HINGVADI GUTIKA IN UDAVARTA YONIVYAPADA. THE PRIMARY OBJECTIVE IS TO STUDY THE EFFECT OF HINGVADI GUTIKA IN UDAVARTA YONIVYAPADA FOR A DURATION OF 60 DAYS. REGULAR ASSESSMENT OF SIGNS AND SYMPTOMS WILL BE DONE. OBSERVATION WILL BE DRAWN FROM THE OUTCOME OF PATIENT. |