| CTRI Number |
CTRI/2022/01/039315 [Registered on: 11/01/2022] Trial Registered Prospectively |
| Last Modified On: |
10/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To observe the effect of Ayurvedic medicine for the treatment of Obesity with abnormal lipid profile |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of an Ayurvedic formulation (Slim MetS) in patients with Metabolic Syndrome (MetS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harbans Singh |
| Designation |
Research officer (Ay), Scientist-2 |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Clinical Research Unit Room No. 217
Moti Bagh Road
Patiala
PUNJAB
147001
India |
| Phone |
09501248820 |
| Fax |
0175-2223663 |
| Email |
dr.harbans@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harbans Singh |
| Designation |
Research officer (Ay), Scientist-2 |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Clinical Research Unit Room No. 217
Moti Bagh Road
PUNJAB
147001
India |
| Phone |
09501248820 |
| Fax |
0175-2223663 |
| Email |
dr.harbans@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harbans Singh |
| Designation |
Research officer (Ay), Scientist-2 |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Clinical Research Unit Room No. 217
Moti Bagh Road
PUNJAB
147001
India |
| Phone |
09501248820 |
| Fax |
0175-2223663 |
| Email |
dr.harbans@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Central Ayurveda Research Institute, Moti Bagh Road, Patiala, Punjab |
|
|
Primary Sponsor
|
| Name |
Desh Bhagat University |
| Address |
Amloh Road, Mandi Gobindgarh |
| Type of Sponsor |
Other [State Private University] |
|
|
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 Harbans Singh |
Central Ayurveda Research Institute |
Clinical Research Unit Room No. 217 Moti Bagh Road Patiala
Patiala
PUNJAB |
09501248820
0175-2223663
dr.harbans@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Desh Bhagat University Amloh Road Mandi Gobindgarh 147301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Slim MetS, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 84 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm (F), and two or more of these criteria:
1. fasting blood glucose >100 mg;
2. systolic blood pressure >135 or diastolic blood pressure >85 mmHg
3. triglyceridemia >150 mg/dl;
4. HDL cholesterolemia < 40 mg/dl (M), < 50 mg/dl(F).
5. Patient willing to participate in the study for 12 weeks.
|
|
| ExclusionCriteria |
| Details |
1. Patients with diabetes mellitus (FBS >126mg/dl);
2. Patients with blood pressure more than 160/100 mmHg.
3. Triglyceridemia > 500 mg/dl;
4. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc).
5. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia.
6. Symptomatic patients with clinical evidence of heart failure, hepatic failure and renal failure (serum creatinine >2 mg/dl).
7. Alcoholics and/or drug abusers.
8. Pregnant and lactating mothers
9. Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in waist circumference (WC)
Change in Body Mass Index (BMI)
Change in Insulin Resistance using Homeostatic model assessment (HOMA-IR) index
Change in Insulin Resistance using quantitative insulin sensitivity check index (QUICKI)
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in lipid profile
Change in systolic and diastolic blood pressure
Change in blood glucose and insulin level
Change in Renal function & liver function
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
17/01/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The metabolic syndrome (MetS) is increasingly being recognized
as a major threat to good health- especially cardiovascular health and its
frequency appears to be increasing in relation to the current epidemic of
obesity. The epidemic of cardiovascular disease emerging in the developing
countries during the past two decades has attracted the attention of
cardiologists, diabetologists, endocrinologists and epidemiologists. It is a
well established fact that all of the ethnic groups in the world, South Asians
have the highest incidence of coronary artery disease (CAD). As we have emerged
as a diabetes capital of the world, the incidence of coronary artery disease is
expected to rise several folds, increasingly affecting younger subsets of our
population who are often in the prime of their lives. The economic and health
care burden on our society is likely to be enormous. A major factor responsible
for this dismal scenario is the occurrence of a peculiar set of metabolic and
cardiovascular abnormalities that affects our society, known as Metabolic
syndrome (MetS). It is a multifaceted syndrome responsible for type 2 diabetes
mellitus, obesity, hypertension, dyslipidaemia, hyperinsulinaemia and
atherosclerotic cardiovascular diseases (ASCVD). Abdominal obesity and insulin
resistance are the main underlying abnormalities in the metabolic syndrome.
Patients of metabolic syndrome present with almost similar co-morbidities to
that of Santarpanaotha Prameha mentioned in Ayurvedic
treaties. Modern drug therapy of metabolic syndrome may be limited by adverse
reactions, requiring alternative therapies. Herbal drugs are supposed to have
benefits with fewer side effects, so there is a need to evaluate these herbal
drugs scientifically. Therefore, it was decided to evaluate the glycaemic improving,
weight reducing, insulin improving and hypolipidaemic effects of an Ayurvedic
herbal formulation (Slim MetS) in patients with metabolic
syndrome. |