| CTRI Number |
CTRI/2023/05/053211 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
YOGA AND KADUKKAI NEI FOR OBESITY (ATHITHOOLAM) |
|
Scientific Title of Study
|
EVALUATION OF THE THERAPEUTIC EFFECTIVENESS OF YOGASANAM AND KADUKKAI NEI IN THE MANAGEMNENT OF ATHITHOOLAM(OBESITY)- A COMPARATIVE , NON RANDOMIZED , DOUBLE ARM, SINGLE CENTRIC CLINIC TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ARUNACHALAM |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
PG scholar
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
Chennai
TAMIL NADU
600047
India |
| Phone |
7010836300 |
| Fax |
|
| Email |
drarunachalamyoga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V MAHALAKSHMI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Siddha |
| Address |
Associate professor
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
Chennai
TAMIL NADU
600047
India |
| Phone |
|
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ARUNACHALAM |
| Designation |
PG STUDENT |
| Affiliation |
National Institute of Siddha |
| Address |
PG Scholar
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
Chennai
TAMIL NADU
600047
India |
| Phone |
|
| Fax |
|
| Email |
drarunachalamyoga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Panndithar Hospital
Natinal institute of siddha
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 ARUNACHALAM |
AYOTHIDOSS PANDITHAR HOSPITAL |
OPD 13
Department of siddhar yoga maruthuvam
AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
Chennai
TAMIL NADU |
7010836300
drarunachalamyoga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
INTERNAL MEDICINE |
KADUKKAI NEI 5ML TWICE A DAY
90 DAYS |
| Comparator Agent |
NIL |
NIL |
| Intervention |
YOGA THERAPY |
RELAXATION TECHNIQUES
PATHAHASTHASANAM
TRIKONASANAM
PAVANAMUKTHSANAM
PATCHIMOTHASANAM
UTHTHANAPADHASANAM
NAVASANAM
FOR 90 DAYS daily 25 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
BMI ABOVE 30
PATIENTS WILLING TO GIVE BLOOD SAMPLES FOR LAB INVESTIGATIONS
PATIENTS WILLING TO SIGN THE INFORMED CONSENT |
|
| ExclusionCriteria |
| Details |
K/H/O TYPE 1 2 DIABETES MELLITUS
K/H/O SYSTEMIC HYPEYTENSION
K/H/O MENTAL DISORDERS
K/H/O POLYCYSTIC OVARIAN DISEASES
K/H/O PREGNANT AND LACTATING WOMEN
K/H/O HYPOTHYROIDISM |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MANAGEMENT OF OBESITY THROUGH BMI THORACIC HIP RATIO HIP WAIST RATIO ARM FOLD THICKNESS LIPID LEVEL BY YOGA AND KADUKKAI NEI FOR 90 DYAS |
MANAGEMENT OF OBESITY THROUGH BMI THORACIC HIP RATIO HIP WAIST RATIO ARM FOLD THICKNESS LIPID LEVEL BY YOGA AND KADUKKAI NEI FOR 90N DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2023 |
| Date of Study Completion (India) |
26/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THE STUDY IS TO EVALUATE THE THERAPEUTIC EFFECTIVENESS OF YOGASANAM AND KADUKKAI NEI IN THE MANAGEMENT OF ATHITHOOLAM (OBESITY) THROUGH BMI, THORACIC HIP RATIO HIP WAIST RATIO ARM FOLD THICKNESS AND LIPID PROFILE AMONG THE PATIENTS AGED 20 TO 50 YEARS WITH NO COMORBIDITIES |