| CTRI Number |
CTRI/2015/06/005899 [Registered on: 09/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
13/02/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic treatment for Metabolic Syndrome a disease which includes obesity, elevated blood pressure, abnormal lipids with early diabetes at one place |
|
Scientific Title of Study
|
Ayurvedic formulation developed for the prevention and management of Metabolic syndrome and cardiovascular risk |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G P I Singh |
| Designation |
Vice Chancellor |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Adesh Institute of Medical Sciences and Research Adesh University
Bathinda
PUNJAB
151109
India |
| Phone |
9815542987 |
| Fax |
|
| Email |
gpisingh.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof G P Dubey |
| Designation |
Distinguished Professor |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Adesh Institute of Medical Sciences and Research Adesh University
Bathinda
PUNJAB
151 109
India |
| Phone |
09450963942 |
| Fax |
|
| Email |
gpdubey13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakendra Singh |
| Designation |
Professor |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Dept. of Cardiology, Adesh Institute of Medical Sciences and Research Adesh University
Bathinda
PUNJAB
151 109
India |
| Phone |
9815409999 |
| Fax |
|
| Email |
rakendrasingh@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute of
Medical Sciences and
Research, Adesh
University Bathinda
Punjab India |
| M/s Arvind Remedies Ltd. 190, Poonamallee High Road, Chennai |
| M/s Varanasi Bio Research Pvt. Ltd. Varanasi,U.P. India |
|
|
Primary Sponsor
|
| Name |
Adesh University |
| Address |
Adesh Institute of
Medical Sciences and
Research, Adesh
University Bathinda
Punjab India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr H S Gill |
Chairman, Adesh Group Adesh Institute of
Medical Sciences & Research Bhatinda Ph.
0164-2742903, 2860001 Mobile: 09814002012
E-mail: adeshfoundation@hotmail.com |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G P I Singh |
Adesh University |
Department of
Community Medicine,
Adesh Institute of
Medical Sciences and
Research, Adesh
University
Bathinda
PUNJAB |
9815542987
gpisingh.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Adesh Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Metabolic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Test formulation containing hydro-alcoholic extract of Salacia parviflora, Tribulus terrestris and Dioscorea glabra in the dose of 500mg twice per day for a period of 6 months. |
The test formulation was prepared in combined form out of the hydro-alcoholic extract of Salacia parviflora, Tribulus terrestris and Dioscorea glabra was given to diagnosed metabolic syndrome patients in two divided doses i.e. 500mg morning at 8.00 Am and 500mg at 8.00 PM for a period of six months. Before clinical trial the test formulation was found safe and non-toxic even in ten times higher doses and its beneficial role was found as anti-obesity, anti-hyperlipidemic, leptin reducing, adiponectin enhancing including improved insulin sensitivity in experimentally designed metabolic syndrome animal model. The safety profile of test formulation was also conducted in Phase-I clinical trial among normal volunteers. In phase-II exploratory clinical trial the test formulation exhibited its potential role on various biological markers related with metabolic syndrome. Following 6 months of treatment with test formulation a significant reduction in body weight, leptin, IL-6, CRP, TNF-α along with improvement in total cholesterol, HDL-c ratio was noticed in metabolic syndrome patients. The endothelial dysfunction also improved and the atherogenic dyslipidemia corrected and risk of atherosclerotic changes were found to be modified under influence of test formulation treatment. |
| Comparator Agent |
The conventional drug Orlistat 120mg (8.00 AM morning and 8.00 PM evening) twice per day for a period of six months |
The conventional drug Orlistat 120 mg twice per day were administered to diagnosed patients of metabolic syndrome. This study has been conducted following standard regulatory norms and effect of drug was evaluated on various obesity markers (BMI, leptin, adiponectin), blood pressure (both systolic and diastolic), lipid profile (TC, HDL-c, LDL-c, VLDL-c and Triglyceride) and insulin resistance. Further, the efficacy of the drug was assessed on leptin, adiponectin, HDL-c & triglyceride ratio, serum insulin including inflammatory markers hsCRP, IL-6 and TNF-α. The pattern of activity of the drug on various markers indicated the beneficial role of the drug in the management of metabolic syndrome. Though, the adverse reactions of conventional drug are also well established therefore, the intervention of novel plant based formulation is of more benefit as regard the safety and efficacy is concern. Whole study has been conducted as per regulatory norms. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Triglycerides>150 mg%
2. Abdominal girth Male > 102 cm and Female > 85 cm
3. BP systolic > 130 mm Hg and Diastolic > 85 mm Hg
4. HDL < 40 mg% in Male and < 50 mg% in Female
5. Fasting Blood Sugar > 100 mg% |
|
| ExclusionCriteria |
| Details |
1. FBS <100 mg%
2. TG <150 mg%
3. BP Systolic < 130 mmHg and Diastolic <85mmHg
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The impact of Ayurvedic formulation on body mass index, lipid profile, blood pressure, leptin and adiponectin level. |
A gradual improvement was noticed in the abnormalities associated with metabolic syndrome. The most effective results were obtained at the end of six months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified atherogenic dyslipidemia along with improvement in feeling of well being and work performance was noticed. |
A gradual improvement was noticed in the abnormalities associated with metabolic syndrome. The most effective results were obtained at the end of six months of treatment. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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 3 |
|
Date of First Enrollment (India)
|
02/01/2009 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1.Sharmistha Singh, Aruna Agrawal, Tanu Priya, G.P.I Singh, K.Ilango and G .P Dubey: Pathophysiology of Metabolic Syndrome – Its Management by Ayurvedic Formulation; World J Pharm Sci 2015; 3(2): 241-250 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized double blinded conventional
controlled clinical trial shall be carried out to validate the beneficial role
of novel poly-herbal formulation beneficial in the prevention of cardiovascular
disorders among metabolic syndrome patients. The age range of metabolic
syndrome will be 40-70 years of both the gender. The modern conventional agent Orlistat shall be used for control
design. The biological potential of test formulation will be evaluated on the
associated markers with metabolic syndrome as described earlier. Minimum 1000
patients of metabolic syndrome shall be included in the clinical trial and will
be followed up for a period of 1 year. The advanced statistical method will be
applied to establish the beneficial role of test formulation in the prevention
and management of metabolic syndrome and associated cardiovascular risk
factors. |