| CTRI Number |
CTRI/2021/12/038852 [Registered on: 22/12/2021] Trial Registered Prospectively |
| Last Modified On: |
26/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Karpas mool kalka in White discharege |
|
Scientific Title of Study
|
A Open Randomized Control Clinical Trial Of Karpas Mool Kalka In Shewetapradara With Special Reference To Leucorrhoea. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Sachin Jagnnath Patil |
| Designation |
Professor |
| Affiliation |
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta, |
| Address |
Prasutitanta And Streerog Opd room no.4
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta,Tal-Walwa Dist- Sangli
416301
Maharashtra
Prasutitanta And Streerog Opd room no.4
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta,Tal-Walwa Dist- Sangli
416301
Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
sachinpatil5190@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Sachin Jagnnath Patil |
| Designation |
Professor |
| Affiliation |
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta, |
| Address |
Prasutitanta And Streerog Opd room no.4
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta,Tal-Walwa Dist- Sangli
416301
Maharashtra
Prasutitanta And Streerog Opd room no.4
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta,Tal-Walwa Dist- Sangli
416301
Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
sachinpatil5190@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Sachin Jagnnath Patil |
| Designation |
Professor |
| Affiliation |
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta, |
| Address |
Prasutitanta And Streerog Opd room no.4
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta,Tal-Walwa Dist- Sangli
416301
Maharashtra
Prasutitanta And Streerog Opd room no.4
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta,Tal-Walwa Dist- Sangli
416301
Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422407301 |
| Fax |
|
| Email |
sachinpatil5190@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Cente Ashta |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Cente Ashta |
| Address |
Ashta Tal- Walwa Dist-Sangli Pincode- 416301 |
| Type of Sponsor |
Private 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 |
| Payal Harishkumar Madhwani |
Dhanvantari Hospital Ashta |
Prasutitanta And Streerog Opd room no.4
Hon.Shri.Annasaheb Dange Ayurved Medical College And Post Graduate Research Centre Ashta Tal- Walwa Dist-Sangli
Maharashtra
416301
India
Sangli
MAHARASHTRA |
7972908623
payalmadhwani933@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: Shwetapradara, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpas mool kalka, Reference: Chakradatta, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Tandulodak), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amalaki beej kalka, Reference: Chakradatta, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient will selected on the basis of signs & symptoms mentioned below:
• Age from 20-45yrs of females patients complaining of shwetapradara.
|
|
| ExclusionCriteria |
| Details |
1)Pregnant women
2)Indication of surgical management and other complications
3)Cervical erosion
4)CA of genital tract
5)STD’s (syphilis, Tricomonas vaginalis)
6)VDRL, HbsAg, HIV positive person.
7)DM,HTN
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Karpas mool kalka in Shwetapradara |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of Karpas mool kalka and Amalaki beej kalka in Shwetapradara |
18 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
07/01/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The term Shwetapradara is a clinical condition characterized by white excessive and persistent discharge from vagina. The clinical picture of Shwetapradara have some sorts of similarity with Leucorrhoea. |