| CTRI Number |
CTRI/2025/06/088766 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate if Siddha Medicine Can help reduce Weight and Body Measurements in People with Moderate Obesity Over 90 Days |
|
Scientific Title of Study
|
An open-labelled, single-centric, randomized prospective clinical trial for evaluating the therapeutic efficacy of a Siddha regimen in the management of Atitula noy, Obesity, Class I and Class II |
| 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 Manjusree S |
| Designation |
Pg scholar |
| Affiliation |
Pg scholar, National institute of siddha |
| Address |
Room no 10/11, Department of Gunapadam, National Institute of Siddha, Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9677875915 |
| Fax |
|
| Email |
manjusree715@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Senthilvel |
| Designation |
Head of the Department |
| Affiliation |
National institute of siddha |
| Address |
Room no 10/11, Department of Gunapadam, National Institute of Siddha, Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8925856333 |
| Fax |
|
| Email |
siddha.senthilvel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Senthilvel |
| Designation |
Head of the Department |
| Affiliation |
National institute of siddha |
| Address |
Room no 10/11, Department of Gunapadam, National Institute of Siddha, Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8925856333 |
| Fax |
|
| Email |
siddha.senthilvel@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
chennai
TAMIL NADU
600047
India |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S MANJUSREE |
Ayothidoss Pandithar Hospital |
Room 10/11
Department of Gunapadam
National institute of siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India
Chennai
TAMIL NADU |
9677875915
manjusree715@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE CERTIFICATE OF APPROVAL |
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 |
| Intervention |
Thiripala Chooranam
Nerunjil Kudineer
Jalamanjari Chenduram |
Thiripala Chooranam(poly herbal powder)
Nerunjil Kudineer(poly herbal decoction)
Jalamanjari Chenduram(herbo-mineral drug)
A Treatment regimen selected for the management of obesity will be advised to consume twice a day for 90 days |
| Comparator Agent |
Thiripala Chooranam
Nerunjil Kudineer
Jalamanjari Chenduram
diet restriction |
Thiripala Chooranam(poly herbal powder) Nerunjil Kudineer(poly herbal decoction) Jalamanjari Chenduram(herbo-mineral drug) A Treatment regimen selected for the management of obesity will be advised to consume twice a day for 90 days along with low calorie diet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
K/C/O Diabetes Mellitus
Obesity-BMI greater than or equal to 30kg/m^2
Obesity class l-BMI 30 to 34.9kg/m^2
Obesity class ll-BMI 35 to 39.9kg/m^2 |
|
| ExclusionCriteria |
| Details |
Vulnerable groups (Pregnancy and lactation)
Hypothyroidism
Malignancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A 5 to 10 percent reduction in BMI and a reduction in anthropometric measurements
from baseline to endpoint.
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the difference in laboratory parameters and Enhanced Quality of Life from
baseline to endpoint |
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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/06/2025 |
| 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="6"
Days="0" |
|
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
|
This open labelled single centric randomized prospective clinical trial to evaluate the therapeutic efficacy of a Siddha regimen Thiripala Chooranam Nerunjil kudineer and Jalamanjari Chenduram for 90 days at Ayothidoss Pandithar hospital chennai in managing class 1 and 2 obesity participants aged 18-60 years with bmi greater than or equal to 30 kg per meter square will be randomized into two groups group 1 siddha regimen only and group two siddha regimen with low calorie diet the primary objective is to achieve a 5 to 10 percent reduction in bmi and anthropometric measurements while secondary objectives include assessing changes in laboratory parameters and quality of life the study includes known case of diabetes mellitus obesity bmi greater than or equal to 30 kg per meter square obesity class one bmi 30 to 34.9 kg per meter square obesity class two bmi 35 to 39.9 kg per meter square and excludes vulnerable groups hypothyroidism and malignancy aiming to provide evidence on the efficacy of siddha medicine in obesity management |