| CTRI Number |
CTRI/2022/03/040774 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preclinical and clinical evaluation of POONAI MEESAI CHOORANAM KUDINEER (Oral administration) in the management of NEPHROTIC SYNDROME |
|
Scientific Title of Study
|
preclinical and clinical evaluation of the effect on oral administration of POONAI MEESAI CHOORANAM KUDINEER in the management of OOTHU SOBAI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Narmatha |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
II year pg scholar,Department of kuzhanthai Maruthuvam Government siddha medical college and hospital, palayamkotai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9943399869 |
| Fax |
|
| Email |
drnarmathaperumal95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D K SOUNDARARAJAN MD S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Department of kuzhanthai maruthuvam,Government siddha medical college and hospital, palayamkotai,Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D K SOUNDARARAJAN MD S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Department of kuzhanthai maruthuvam,Government siddha medical college and hospital, palayamkotai,Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr P Narmatha |
| Address |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
| 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 P Narmatha |
Government Siddha Medical College and Hospital Palyamkottai |
Op no.7,Department of kuzhanthai maruthuvam,Government siddha medical college and hospital
Tirunelveli
TAMIL NADU |
9943399869
drnarmathaperumal95@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: N049||Nephrotic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Poonai meesai chooranam kudineer |
15-30ML BD Before food
For 30 days |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Oedema due to renal impairment |
|
| ExclusionCriteria |
| Details |
Children above 12 years
Children below 3 years
Hypothyroidism
Cushing syndrome
Oedema due to drug allergy
Oedema mimics obesity in children
Acute glomerular nephritis
Chronic glomerular nephritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN SYMPTOMS |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/03/2022 |
| Date of Study Completion (India) |
17/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is single arm trails for preclinical and clinical evaluation of the effects on oral administration of poonai meesai chooranam kudineer in the management of oothu sobai |