| CTRI Number |
CTRI/2014/08/004838 [Registered on: 07/08/2014] Trial Registered Prospectively |
| Last Modified On: |
05/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and safety study of dietary supplements in chronic smokers individuals having mild to moderate hyperlipidemia |
|
Scientific Title of Study
|
Efficacy and safety study of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OLS-SH/06-14 VERSION 01 05/06/2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkateshwarlu K |
| Designation |
Ayurvedic Physician |
| Affiliation |
Sreenivasa Clinic and Diabetic Care Centre |
| Address |
Sreenivasa Clinic and Diabetic Care Centre,
near Avalahalli BDA park,
Girinagar,Bangalore
Bangalore
KARNATAKA
560085
India |
| Phone |
|
| Fax |
|
| Email |
drvenkatesh64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HN Shivaprasad |
| Designation |
Vice President - Research and Technical Affairs |
| Affiliation |
Olive Lifesciences Pvt Ltd |
| Address |
M/s. Olive Lifesciences (P) Ltd,
no.03, PDS Towers, Sanjeevini nagar, Sahakarnagar, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
|
| Fax |
|
| Email |
shiv@olivelifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HN Shivaprasad |
| Designation |
Vice President - Research and Technical Affairs |
| Affiliation |
Olive Lifesciences Pvt Ltd |
| Address |
M/s. Olive Lifesciences (P) Ltd,
no.03, PDS Towers, Sanjeevini nagar, Sahakarnagar, Bangalore
Bangalore
KARNATAKA
560092
India |
| Phone |
|
| Fax |
|
| Email |
shiv@olivelifesciences.com |
|
|
Source of Monetary or Material Support
|
| Olive Lifesciences Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Olive Lifesciences Pvt Ltd |
| Address |
No.3, PDS Towers, Sanjeevini nagar, Kodigehalli main road, Sahakarnagar, Bangalore-560092 |
| Type of Sponsor |
Other [Nutraceutical Industry] |
|
|
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 Venkateshwarlu K |
Sreenivasa clinic and diabetic care centre |
197, Avalahalli, Near-Bda Park, Banashankari 3rd Stage, Bangalore, Karnataka 560085
Bangalore
KARNATAKA |
9945232107
drvenkatesh64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic smokers; mild to moderate hyperlipidemia
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BioTurmin (Curcuma longa standardized extract) |
250 mg capsule taken orally after food; twice daily (500 mg/day) for 60 days |
| Intervention |
BioTurmin-WD (Curcuma longa water dispersible extract) |
250 mg capsule taken orally after food; twice daily (500 mg/day) for 60 days |
| Intervention |
MaQxan (Tagetes erecta flower extract) |
250 mg capsule taken orally after food; twice daily (20 mg/day) for 60 days |
| Comparator Agent |
Placebo |
250 mg capsule taken orally after food; twice daily for 60 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Men >20 years.
Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC >200 mg/dL and/or HDL-C <40 mg/dL).
Being mentally competent and able to understand all study requirements and sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
Patients with Chronic obstructive pulmonary disease (COPD).
Women.
Patients with severe liver, renal, cardiac or brain diseases.
Unable to complete follow up.
Subjects on any medication like diuretics.
Allergic to any medication.
With a history of alcohol and/or drug abuse.
|
|
|
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 urine cotinine and serum oxidative stress marker (malondialdehyde) level |
Baseline, on day 30 and 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in serum lipid profile |
Baseline, on day 30 and 60 |
| Safety and tolerability [physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology (CBC), biochemical tests (serum urea, serum creatinine), liver function test and urine analysis]. |
Baseline, on day 30 and 60 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2014 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of dietary supplements on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia. The primary outcome measure will be change from baseline in urine cotinine level and serum oxidative stress marker level after 30 and 60 days of treatment. The secondary outcome measure will be safety and tolerability. |