| CTRI Number |
CTRI/2015/09/006150 [Registered on: 03/09/2015] Trial Registered Prospectively |
| Last Modified On: |
27/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic study for the treatment of Obesity |
|
Scientific Title of Study
|
Clinical Evaluation of Certain Ayurvedic Formulations in the
Management of Sthoulya (Obesity)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maheswar Thugutla |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Vector Borne Diseases,
New Rajeev Nagar, Payakapuram, Vijayawada.
Krishna
ANDHRA PRADESH
India
National Ayurveda Research Institute for Vector Borne Diseases,
New Rajeev Nagar, Payakapuram, Vijayawada.
Krishna
ANDHRA PRADESH
India
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
08662402535 |
| Fax |
08662402144 |
| Email |
mahesh_rri@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maheswar Thugutla |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Vector Borne Diseases,
New Rajeev Nagar, Payakapuram, Vijayawada.
Krishna
ANDHRA PRADESH
India
National Ayurveda Research Institute for Vector Borne Diseases,
New Rajeev Nagar, Payakapuram, Vijayawada.
Krishna
ANDHRA PRADESH
India
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
08662402535 |
| Fax |
08662402144 |
| Email |
mahesh_rri@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maheswar Thugutla |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Vector Borne Diseases,
New Rajeev Nagar, Payakapuram, Vijayawada.
Krishna
ANDHRA PRADESH
India
National Ayurveda Research Institute for Vector Borne Diseases,
New Rajeev Nagar, Payakapuram, Vijayawada.
Krishna
ANDHRA PRADESH
India
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
08662402535 |
| Fax |
08662402144 |
| Email |
mahesh_rri@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences
JLNBCAH Anusandhan Bhawan
61-65, Institutional Area
Opposite D Block
Janakpuri, New Delhi - 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
JLNBCAH Anusandhan Bhawan, 61-65, Opp D Block, Institutional area, Opp D block, Janakpuri, New Delhi 520058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr T Maheswar |
National Ayurveda Research Institute for Vector Borne Diseases, |
Room No 207, Second floor
New Rajeev Nagar, Payakapuram, Vijayawada
Krishna
ANDHRA PRADESH |
9441415266
08662402144
mahesh_rri@yahoo.co.in |
| Dr K K Rath |
National Research Institute of Ayurvedic Drug Development |
Room No 29, First floor, 4 CN Block, Sector 5, Bidhan Nagar, Kolkata - 700091
Kolkata
WEST BENGAL |
9874612213
03323671001
drkkratha.ayu@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I Navaka Guggulu, Brihat Manjishtadi Kashaya
Group II Trushanadi Guggulu, Ayaskriti |
Group-I
1. Navaka guggulu (Bhaishajya ratnavali 39/43)
Dose : 1 gm TDS
Dosage form : Tablet
Route of Administration : Oral
Time of Administration : Thrice a day after food
Anupana : Sukoshna jala
Duration of therapy : 12 weeks
2. Brihad manjishtadi kwatham (AFI-part1-pg.no.59)
Dose : 50 ml TDS
Dosage form : Kashaya
Route of Administration : Oral
Anupana : Water
Time of Administration : Thrice a day after food
Duration of therapy : 12 weeks
Group-II
1. Tryushanadi guggulu : (Bhavaprakasa uttarakhanda 39chapter 31 sloka)
Dose : 1 gm TDS
Dosage form : Tablet
Route of Administration : Oral
Time of Administration : thrice a day after food
Anupana : Sukoshna jala
Duration of therapy : 12 weeks
2. Ayaskriti (AFI-part1 -pg.no.6)
Dose : 30 ml TDS
Dosage form : Arishta
Route of Administration : Oral
Anupana : Equal quantity water
Time of Administration : Thrice a day after meals.
Duration of therapy : 12 weeks
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex with age above 25years and below 60 years.
2. Obese patient having 20% excess weight than desirable weight according to height, sex and age / age adjusted BMI above 85th percentile (Indian standard)
3. WHR- Waist Hip circumference Ratio > 0.95 in males & > 0.8 in females.
|
|
| ExclusionCriteria |
| Details |
1. Age below 25 years and above 60 years
2. Obesity secondary to or associated with Hypothyroidism, Hyper tension, Diabetes mellitus, Hyperlipidemia or Cushing’s syndrome.
3. Pregnancy and lactation.
4. Patients who cannot report in person once in 2 weeks in the OPD
5. Patients with poorly controlled Hypertension ( >160/100 mmHg)
6. Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 8
7. Patients who have a past history of Arterial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
8. Symptomatic patient with clinical evidence of Heart failure.
9. Known HIV & Viral Hepatitis positive cases
10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dl), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
11. Alcoholics, smokers, and/or drug abusers
12. H/o hypersensitivity to any of the trial drugs or their ingredients
13. Patients who have completed participation in any other clinical trial during the past six months.
14. Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Obesity in EOSS (Edmonton obesity scoring system)
|
Total Study Period-2 years
Preparation-3 months
Recruitment-18 months
Statistical Analysis-3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Waist Hip Circumference
BMI
Changes in Symptoms |
Treatment period - 12 weeks
Follow up 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
21/09/2015 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sthoulya (obesity is a condition in which there is an excessive accumulation of fat in the body. This disease is metabolic disease generally occurs in affluent societies. It is associated with increased mortality by predisposing to the development of diseases like Diabetes mellitus, Hypertension, Atherosclerosis, Heart disease, Arthritis, Infertility etc. Obesity is most prevalent in middle age, but it can occur at any stage of life.It is highprevalent in socio economic group. There are certain professions in which physical exertion is low are more prone to obesity. female are more affected than males. Endocrine factors and energy imbalance are also responsible for the obesity.
Obese patients having 20% excess weight than desirable weight according to height, sex, and age of both male and female patients will be selected from O.P.D/ I.P.D of the Institute as per Inclusion and Exclusion criteria. The cases will be selected randomly in two groups. First group patients will be studied with classical Ayurvedic drugs Navaka guggulu (Bhaishjya Ratnavali 39/43)1gm TDS and Brihat Manjishtadi Kwatha (AFI Part I PAge 59) 50 ml TDS Second group with Trushnadi guggulu(Bhava Prakash Uttarakhada 3) gms TDS and Ayaskriti(AFI part I Page 6) ml TDS for weeks. Assesment will be done on every fortnight with clinical parameters, BMI, WHR and Edmonton Obesity Scoring Systems(EOSS). Laboratory investigation will be carried out before and after completion of 12 weeks treatment. The sample size of the study is 240(120 for each centre) ie 60 in eachgroup and the total duration of the study is 2 years. |