| CTRI Number |
CTRI/2020/05/025001 [Registered on: 04/05/2020] Trial Registered Prospectively |
| Last Modified On: |
15/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study on PALATTIRIKKATI CURANAM in the management of Atitulam (Obesity) |
|
Scientific Title of Study
|
An Open Labelled Phase II Non-Randomized Clinical Control Study of PALATTIRIKKATI CURANAM in the management of ATITULAM (Obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rosalyn Shobanaa Mathivathanan |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College & Hospital |
| Address |
Government Siddha Medical College & Hospital,
Palayamkottai, Tirunelveli, Tamil Nadu.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7339203756 |
| Fax |
|
| Email |
rosalyn.shobanaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Komalavalli |
| Designation |
Associate Professor |
| Affiliation |
Government Siddha Medical College & Hospital |
| Address |
Dept. Of Pothu Maruthuvam
GSMC&H, Palayamkottai - 627002.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan |
| Designation |
Professor, Head of the Department |
| Affiliation |
Government Siddha Medical College & Hospital |
| Address |
Dept. Of Pothu Maruthuvam
GSMC&H, Palayamkottai - 627002.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient Department and In Patient Department |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI, TIRUNELVELI, TAMIL NADU 627002 |
| 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 |
| ROSALYN SHOBANAA MATHIVATHANAN |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
OP NO: 6 & 10;
IP NO: 19,20,22,23 & 27
OPD AND IPD OF POTHU MARUTHUVAM
Tirunelveli
TAMIL NADU |
7339203756
rosalyn.shobanaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Palattirikkati Curanam |
2g twice a day after meals for 90 days in 60 patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI- More than 27 up to 35
WHR- More than 0.85 up to 1.00
Diagnosed Hypertension, Diabetes Mellitus
|
|
| ExclusionCriteria |
| Details |
age below 20 and above 65
BMI - Below 27 & above 35
WHR - Below 0.85 & above 1.00
Renal Diseases
Endocrine diseases
Familial obesity
Pregnancy
Lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| weight and complains reduction during treatment or after treatment |
weight and complains reduction during treatment or after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Find the pre clinical study of the trial drug.
To find out the cost effectiveness of the trial drug
To find out the prevalence of atitulam among the patients.
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/05/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an Open Labelled Phase II Non-Randomized Clinical Control Study to evaluate the therapeutic effect of PALATTIRIKKATI CURANAM in the management of ATITULAM (Obesity). The trial drug will be administrated at the dose 2g twice a day after meals for 90 days in 60 patients. The trial period will be carried out at Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu - 627002. The primary outcome will be to evaluate the therapeutic effect of the Trial Drug in the management of Atitulam. Secondary outcome will be the assessment of safety profile, pharmacological and biochemical parameters of trial drug. In case of any adverse effect is noted it will be reffered to the pharmacovigillence department of SCRI. Futher management for the patients will be given in OPD facility. |