| CTRI Number |
CTRI/2024/06/068398 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| 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 sitamishrit dhatriras in pittaj yonivyapad(pelvic inflammatory disease) |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of sitamishrit dhatriras in pittaj yonivyapad |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pallavi Nakhate |
| Designation |
MS scholar |
| Affiliation |
Dr. D. Y. Patil college of ayurved and research Centre pimpri pune |
| Address |
Opd no 2 streerog evam prasutitantra Dr. D. Y. Patil college of ayurved and research Centre pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9975255855 |
| Fax |
|
| Email |
pallavinakhate29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Patil |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil college of ayurved and research Centre pimpri pune |
| Address |
Opd no 2 streerog evam prasutitantra Dr. D. Y. Patil college of ayurved and research Centre pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Nakhate |
| Designation |
MS scholar |
| Affiliation |
Dr. D. Y. Patil college of ayurved and research Centre pimpri pune |
| Address |
Opd no 2 streerog evam prasutitantra Dr. D. Y. Patil college of ayurved and research Centre pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9975255855 |
| Fax |
|
| Email |
pallavinakhate29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of ayurved and research Centre pimpri pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Pallavi Nakhate |
| Address |
Dr. D. Y. Patil college of ayurved and research Centre 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 Pallavi Nakhate |
Dr. D. Y. Patil college of ayurved and research Centre pimpri pune |
Opd and ipd streerog evam prasutitantra department Dr. D. Y. Patil college of ayurved and research Centre pimpri pune 411018
Pune
MAHARASHTRA |
9975255855
pallavinakhate29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N948||Other specified conditions associated with female genital organs and menstrual cycle. Ayurveda Condition: PITTAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: sitamishrit dhatriras, Reference: yogratnakar yonivyapad chikitsa, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -sita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married woman, non pregnant women, age group between 20-45 years, patients with lakshana of pittaj yonivyapad- yonidaha(burning sensation at vulval region), adhik raj straav(heavy menstrual bleeding) |
|
| ExclusionCriteria |
| Details |
Sutika, history of Diabetes mellitus, hypertension, asthama, known case of cervical cancer, sexually transmitted diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of sitamishrit dhatriras in pittaj yonivyapad which will be assesed by the symptoms yonidaha (burning sensation at vulval region), and adhik raj straav (heavy menstrual bleeding) |
14 days study with follow up on 7th , 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe th adverse effect of sitamishrit dhatriras |
14 days study with follow up on 7th , 14th day |
|
|
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)
|
20/06/2024 |
| 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 evaluate the efficacy of sitamishrit dhatriras in pittaj yonivyapad. Total 35 patients will be enrolled and 20 ml swaras will be given twice a day after meal for 15 days .The age group taken for study is 20 to 45 years women. The final conclusion will be drawn on the the basis of
statistical methods. |