| CTRI Number |
CTRI/2024/10/075875 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Use Of Ashwattha Twak Kwatha Vaginal Wash And Brihatyadi Kwatha Vaginal Wash In The Management Of Yonigata Shwetastrava |
|
Scientific Title of Study
|
A Randomised Controlled Clnical Trial To Evaluate The Efficacy Of
Ashwattha Twak Kwatha Yonidhavana And Brihatyadi Kwatha Yonidhavana In
The Management Of Yonigata Shwetastrava |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Shankar Thorat |
| Designation |
PG Scholar (M.S Prasuti Tantra & Streerog) |
| Affiliation |
Tilak Ayurved Mahavidyalay Pune |
| Address |
Dept Of Prasuti Tantra & Streerog
Tilak Ayurved Mahavidyalaya,
583/2, Rasta Peth, Pune- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
8082311297 |
| Fax |
|
| Email |
sneha9766@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rucha Rahul Ganu |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalay Pune |
| Address |
Dept Of Prasuti Tantra & Streerog
Tilak Ayurved Mahavidyalaya,
583/2, Rasta Peth, Pune- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9822376936 |
| Fax |
|
| Email |
ganu.rucha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rucha Rahul Ganu |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalay Pune |
| Address |
Dept Of Prasuti Tantra & Streerog
Tilak Ayurved Mahavidyalaya,
583/2, Rasta Peth, Pune- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9822376936 |
| Fax |
|
| Email |
ganu.rucha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalay 583/2, Rasta Peth, Pune- 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalay Pune |
| Address |
583/2, Rasta Peth, Pune- 411011 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrSneha Thorat |
Tarachand Hospital Pune |
Opd No. 11 ,Prasuti Tantra And Streerog Ward 583/2, Rasta Peth, Pune- 411011
Pune
MAHARASHTRA |
8082311297
sneha9766@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.G.Naik Ethics Committee T.A.M.V Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Yonidhavana | (Procedure Reference: चरक चिकितà¥à¤¸à¤¾ 30/ 61, Procedure details: Duration- 7 days for 3 cycles
PROCEDURE-
Purvakarma-
- Consent will be taken
- Participant will be asked to void urine before procedure.
- Before starting the procedure, all aseptic measures will be taken
- Fresh kwatha will be prepared.
Pradhankarma-
- Lithotomy position will be given to participant.
- Enema pot filled with koshna kwatha will be kept at height 6 feet from the ground.
- Firstly, the external genitalia will be cleaned with kwatha
- Douche cannula will be inserted in vaginal opening.
- Prathamavarta will be washed out with Ashwattha kwatha.
Pashchatkarma-
- Participant will be given supine position with flexed knees for 10 mins.
Follow up- Participant will be called daily for 7 days after menses for yonidhavana procedure)
(1) Medicine Name: Ashwattha twak kwatha, Reference: à¤à¤¾à¤µà¤ªà¥à¤°à¤•à¤¾à¤¶ निघंटॠवटादि वरà¥à¤—/ 3, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Yonidhavana | (Procedure Reference: चरक चिकितà¥à¤¸à¤¾ 30/ 61, Procedure details: Duration- 7 days for 3 cycles PROCEDURE- Purvakarma- - Consent will be taken - Participant will be asked to void urine before procedure. - Before starting the procedure, all aseptic measures will be taken - Fresh kwatha will be prepared. Pradhankarma- - Lithotomy position will be given to participant. - Enema pot filled with koshna kwatha will be kept at height 6 feet from the ground. - Firstly, the external genitalia will be cleaned with kwatha - Douche cannula will be inserted in vaginal opening. - Prathamavarta will be washed out with Brihatyadi kwatha. Pashchatkarma- - Participant will be given supine position with flexed knees for 10 mins. Follow up- Participant will be called daily for 7 days after menses for yonidhavana procedure)
(1) Medicine Name: Brihatyadi kwatha, Reference: सà¥à¤¶à¥à¤°à¥à¤¤ उतà¥à¤¤à¤°à¤¤à¤‚तà¥à¤° 38/27, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age between 20- 45 years married female participants complaining of vaginal discharge.
• Participants having cervical erosion
• Participants complaining of pv white discharge with itching at vaginal area and staining of
undergarments. |
|
| ExclusionCriteria |
| Details |
Pregnant women
• Participants with sexually transmitted diseases
• Known case of anaemia
• Known case of diabetes mellitus
• Serology positive participants for HIV, HbSAg, VDRL
• Participants with cervical/ vaginal/ endometrial malignancy
• Participants with cervical polyp
• Participants with procedentia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant difference in reduction in Yonigata Shwetastrava |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparatively reduction of Yonigata Shwetastrava is more when Yonidhavana is done by Ashwattha twak kwatha |
3 Month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/11/2024 |
| 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="0" |
|
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
|
Objective- To study the efficacy of Ashwattha twak kwatha yonidhavana and Brihatyadi kwatha yonidhavana in the management of yonigata shwetastrava.
Group A- Yonidhavana with Ashwattha twak kwatha
Group B- Yonidhavana with Brihatyadi kwatha
Patients having complaints of Yonigata Shwetastrava and white discharge on per speculum examination with cervical erosion
Assessment criteria- The study will be strictly based on the assessment of subjective parameter by grading them Subjective Parameter -Pv white discharge, yonikandu, gandha, strava varna, consistency
Assessment of symptoms- Yonidhavana will be given for 7 days after menses. During each visit patient will be questioned regarding the clinical features mentioned in the assessment criteria
CONCLUSION- The result will be recorded before and after treatment and conclusion will be drawn on the basis of statistical analysis. End point- There will be significant decrease in yonigata shwetastrava
Follow up- After next menses. Yonidhavana will be given for 7 days after menses for 3 consecutive cycles |