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Trial registered on ANZCTR


Registration number
ACTRN12613001053718
Ethics application status
Approved
Date submitted
30/07/2013
Date registered
20/09/2013
Date last updated
20/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Turmeric and Kalongi in Metabolic syndrome
Scientific title
Effect of Turmeric, Kalongi and its combination in improving the parameters of Metabolic syndrome in adults -a randomized controlled trial. – TAK-MS Trial
Secondary ID [1] 282931 0
Nil
Universal Trial Number (UTN)
Trial acronym
TAK-MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 289746 0
Condition category
Condition code
Alternative and Complementary Medicine 290081 290081 0 0
Herbal remedies
Metabolic and Endocrine 290119 290119 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four parallel groups will be given intervention or placebo for 8 weeks. Look alike capsules will be used and the dose will be administered in 2 divided doses. Compliance will be encouraged by daily phone messages and it will be measured by drug diary. Refilling will be done when patients return the blister packs of capsules on a weekly basis.

Group 1: Kalongi (Nigella Sativa) group (2 gm/day)
Group 2: Turmeric (Curcuma Longa) group (3.2 gm/day)
Group 3: Combination of Turmeric and Kalongi group (1.6 gm +1 gm/day)
Group 4: Placebo (Wheat) group (2gm /day)
Intervention code [1] 287630 0
Treatment: Other
Intervention code [2] 287631 0
Prevention
Comparator / control treatment
The Placebo (Wheat) group (2gm /day) will receive look alike capsules just like the other 3 groups in 2 divided doses for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 290128 0
Improvement in multiple parameters of Metabolic syndrome
( Body weight/ waist circumference reduction and Blood pressure control measured by mercury sphyngmomanometer, Triglycerides, fasting blood sugar and serum HDL measured by cobas c111)
Timepoint [1] 290128 0
measured at baseline, 4 and 8 weeks
Primary outcome [2] 290149 0
Improvement in insulin resistance measured by fasting serum insulin levels measured by ELECSYS Insulin Assay
Timepoint [2] 290149 0
measured at baseline and 8 weeks of intervention
Primary outcome [3] 290150 0
improvement in inflammatory markers like C-reactive protein measured by cobas c111
Timepoint [3] 290150 0
measured at baseline and 8 weeks of intervention
Secondary outcome [1] 303985 0
body fat, muscle, bone percent (measured through bio impedence).
Timepoint [1] 303985 0
2, 4, 6 and 8 weeks of Randomization
Secondary outcome [2] 304022 0
Adverse effect of treatment.
Timepoint [2] 304022 0
questions will be asked for any complains every week for 8 weeks monitoring adverse effects like nausea, dyspepsia, intolerance etc by a physician. participants will also be given an emergency contact number for any urgent symptoms they would like to report.

Eligibility
Key inclusion criteria
Obese males residing and permanent residents of Hijrat colony with a waist circumference of or >90 cm with any 2 more features of Metabolic syndrome (MS) who are not on any regular medications for Diabetes (pre-Diabetic), Dyslipidemia, blood pressure (pre hypertensive) or obesity and do not require any medications as per ATP III guidelines and American Diabetic Association guidelines for control of Diabetes or Hypertension.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
*Patients with known Diabetes, Hypertension or Coronary Heart disease or who require immediate pharmacological treatment.
*Patients with wheat allergy.
*Patients already taking Herbal supplements.
*Patients on medications for Hyperlipidemia or Obesity.
*Debilitated patients or patients on regular medications for chronic diseases like steroids, immunosuppressants and Warfarin will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size is calculated for a 5 % level of significance and a power of 80%. Assuming the population standard deviation of 3.62 from a previous study (Bhatti A, Berntorp K, Rehman F. Effect of prophetic medicine Kalonji on lipid profile of human beings, an in vivo approach. W Appl Sci J. 2009;6:1053-7), a sample of 52 in each group will be required to determine an effect size of 40%. Assuming a 20% non- participation rate, 62 subjects in each group will be approached.

Data will be entered and analyzed on SPSS version 20.0 and Graph pad prism. Means for quantitative data and frequencies, proportions and percentages for categorical data will be calculated. For quantitative data, paired and unpaired students t test will be used to compare the means within and between groups respectively. One way Anova will be used to compare the means between various groups followed by Tukey’s and Dunett’s tests for multiple comparisons. For categorical data, chi-square will be used to compare differences between groups. If the data is not normally distributed, to compare means, Wilcoxin signed rank sum test will be used for paired data and Mann Whitney U test for unpaired data. P values <0.05 will be considered statistically significant (Confidence interval of 95%).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
248
Accrual to date
Final
Recruitment outside Australia
Country [1] 5254 0
Pakistan
State/province [1] 5254 0
Sindh

Funding & Sponsors
Funding source category [1] 287707 0
University
Name [1] 287707 0
Aga Khan University Medical College,
Country [1] 287707 0
Pakistan
Primary sponsor type
University
Name
Aga Khan University Medical College,
Address
Aga Khan University Hospital, Stadium Road, Karachi-74800,Pakistan.
Country
Pakistan
Secondary sponsor category [1] 286437 0
Individual
Name [1] 286437 0
Professor Anwar-ul-Hassan Gilani
Address [1] 286437 0
Professor of Pharmacology, Department of Biological and Biomedical Sciences, Aga Khan University Medical College, Stadium road, Karachi-74800,Pakistan.
Country [1] 286437 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289664 0
Ethical Review Committee (Aga Khan University Hospital)
Ethics committee address [1] 289664 0
Aga Khan University Hospital, Stadium Road, Karachi 74800,Pakistan
Ethics committee country [1] 289664 0
Pakistan
Date submitted for ethics approval [1] 289664 0
03/10/2011
Approval date [1] 289664 0
11/01/2012
Ethics approval number [1] 289664 0
2042-BBS-ERC-11

Summary
Brief summary
The metabolic syndrome is a combination of certain metabolic abnormalities including Obesity, Diabetes, Dyslipidemia and Hypertension. These in combination are associated with increased risk of coronary heart disease, stroke, and cardiovascular mortality. South Asian countries including Pakistan contribute to the highest proportion of cardiovascular disease burden when compared with any other region globally. The management of early metabolic syndrome without overt Hypertension, Dyslipidemia and Diabetes is based on increasing physical activity and dietary modifications, which is a challenge for many patients. Complementary medicines including herbs like Turmeric and Kalongi are widely accepted and are a part of diet in many Asian countries. These can be used to prevent or as an adjuvant to control chronic diseases like Metabolic syndrome with fewer side effects, better acceptability and cost effectiveness. Therefore this study was done to determine the effectivenees of commonly used herbs like Kalongi and Turmeric in improving the parameters of Metabolic syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41854 0
Dr Faridah Amin
Address 41854 0
Dept. Biological and Biomedical Sciences,
Aga Khan University Hospital, Stadium Road,
Karachi-74800,Pakistan.
Country 41854 0
Pakistan
Phone 41854 0
+92 21-34864566
Fax 41854 0
Email 41854 0
faridah.amin@aku.edu
Contact person for public queries
Name 41855 0
Dr Faridah Amin
Address 41855 0
Contact person is the principal investigator and PhD scholar in Aga Khan University.
A32/3, street 9, BathIsland, Clifton, Karachi- 75600, Pakistan
Country 41855 0
Pakistan
Phone 41855 0
+92 3212701086
Fax 41855 0
Email 41855 0
faridah.amin@bluedotpk.com
Contact person for scientific queries
Name 41856 0
Dr Faridah Amin
Address 41856 0
Dept. Biological and Biomedical Sciences,
Aga Khan University Hospital
Stadium Road, Karachi-74800, Sindh, Pakistan
Country 41856 0
Pakistan
Phone 41856 0
+92 21-34864566
Fax 41856 0
Email 41856 0
faridah.amin@aku.edu

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