| CTRI Number |
CTRI/2023/10/058319 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Treatment] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial of Pathya Amalakadi Decoction in management of Leucorrhoea. |
|
Scientific Title of Study
|
Clinical trial of Pathya Amalakadi Kashaya in management of Shweta Pradara (Leucorrhoea). |
| 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 L Venkata Rathnakar |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 13, Department of Prasuti Tantra and Stree Roga, Shree Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpettai, Chennai- 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9840340826 |
| Fax |
|
| Email |
drlrathnakar@sjsach.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Venkata Rathnakar |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 13, Department of Prasuti Tantra and Stree Roga, Shree Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpettai, Chennai- 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9840340826 |
| Fax |
|
| Email |
drlrathnakar@sjsach.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Balaram Kamble |
| Designation |
P.G. Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 13, Department of Prasuti Tantra and Stree Roga, Shree Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpettai, Chennai- 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9137304446 |
| Fax |
|
| Email |
kamblepriyanka659@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Prasuti Tantra and Stree Roga Outpatient Department, Nazarathpettai, Chennai- 600123 |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Balaram Kamble |
| Address |
Room no 13, Department of Prasuti Tantra and Stree Roga, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpettai, Chennai- 600123 |
| 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 Priyanka Kamble |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room no 13, Department of PTSR, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpeth, Chennai 600123
Thiruvallur
TAMIL NADU |
9137304446
kamblepriyanka659@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathya Amalakadi Kashaya , Reference: Sahasrayoga Kashaya Yoga Prakaran, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patient having clinical features of Shweta Pradara.
Patient complaining of vaginal discharge as the cardinal symptom.
|
|
| ExclusionCriteria |
| Details |
Unmarried women.
Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in white discharge of Shweta Pradara. |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/10/2023 |
| 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="0"
Months="0"
Days="30" |
|
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
|
Shweta Pradara is a condition in which there is a whitish discharge from the vagina. The study titled ’Clinical trial of Pathya Amalakadi Kashaya in management of Shweta Pradara (Leucorrhoea)’ is a single-arm
open-label observational clinical trial in which 40 married female patients from 18 yrs to 50
yrs having clinical features of Shweta Pradara and complaining of
vaginal discharge as the cardinal symptom will
be selected for the study excluding pregnant woemen. The patients will be
tested for urine routine and
microscopic and vaginal wet smear before the study. Later, they will be administered
Pathya Amalakadi Kashaya 50 mL twice daily half an hour before food in lukewarm stage with
10 mL of Madhu as the Prakshepa Dravya for 30 days. After completion of course,
patients will be advised to report 15 days after completion of the medicine
course. Three follow-ups will be conducted with a gap of 15 days between each follow-up.
We will evaluate the efficacy of the selected drug on Shweta Pradara (Leucorrhoea).
The primary outcome will be to assess the improvement in the patient mainly on the
basis of relief in the signs and symptoms of the disease. Further recurrence in the signs & symptoms will be recorded during the follow-up study.
|