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CTRI Number  CTRI/2017/04/008286 [Registered on: 03/04/2017] Trial Registered Prospectively
Last Modified On: 03/04/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   This is a three group study on the effectiveness and safety of Curcuma caesia for weight management. 
Scientific Title of Study   A randomized,double blind,placebo controlled,three group study to evaluate the comparative efficacy and safety of Curcuma caesia and Forskolin and Curcuma caesia for weight management in obese patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL/51/FCC/JUL/16V1.028-JUL-16  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivaraj KK 
Designation  Consultant 
Affiliation  Pristine Hospital 
Address  No. 877, Dr Modi Hospital Road,2nd Stage Extn., West Chord Road, Bangalore.

Bangalore
KARNATAKA
560086
India 
Phone  9035209089  
Fax    
Email  shivarajkk09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kiran Vuppala 
Designation  Senior Manager 
Affiliation  ClinWorld(P)Ltd. 
Address  19/1 & 19/2,I Main,II Phase,Peenya Industrial Area,Bangalore.

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  kiran@clinworld.org  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian 
Designation  Chief Executive Officer 
Affiliation  Syncretic Clinical Research Servicea 
Address  # 4, 5th Cross, 11th Main Road, Vasanthnagar, Bangalore, Karnataka.

Bangalore
KARNATAKA
560052
India 
Phone  0997258010  
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
Sami Labs Limited 19/1 & 19/2, I Main,II Phase, Peenya Industrial Area,Bangalore, Karnataka.560058.  
 
Primary Sponsor  
Name  Sami Labs Limited 
Address  19/1 & 19/2 I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560 058. 
Type of Sponsor  Other [Marketer & manufactuer of phytonutrients,ayurvedic,herbal extracts,probiotics etc.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivaraj K K  Pristine Hospital  No. 877,Dr Modi Hospital Road,General Physician,2nd Stage Extn.,West Chord Road,Bangalore.560086.
Bangalore
KARNATAKA 		 9035209089

shivarajkk09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pristine Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult male and/or female obese or overweight patients.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcuma caesia  One capsule twice a day for 90 days. 
Intervention  Curcuma caesia and Forskolin  One capsule twice a day for 90 days. 
Comparator Agent  Placebo  One capsule twice a day for 90 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Male and/or female patients.
2 Age between 20 to 55 years.
3 BMI between greater than 35 to 40 kg/m2.
4 Willing to come for regular follow up visits.
5 Able to give written informed consent. 
 
ExclusionCriteria 
Details  1 Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months.
2 Pathophysiologic or genetic syndromes associated with obesity like Cushing’s syndrome, Turner’s syndrome, Praderwilli syndrome.
3 Patients with evidence of malignancy.
4 History of poorly controlled Diabetes Mellitus. Glycosylated haemoglobin greater than 10 percent.
5 Patients on prolonged greater than 6 weeks medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
6 Symptomatic patient with clinical evidence of Heart failure.
7 History of HIV and other viral infections.
8 Prior surgical therapy for obesity.
9 History of hypersensitivity to any of the herbal extracts or dietary supplement.
10 Pregnant or lactating woman.
11 Patients who have completed participation in any other clinical trial during the past six months.
12 Any other condition which the Principal Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Change in body weight and BMI.
2 Change in DEXA analysis.
3 Change in Lipid Profile.
4 Change in anthropometric measurements.
5 Clinical Photographs. 		 1 Change in body weight and BMI(Screening,Day30,Day60 and Day90).
2 Change in DEXA analysis(Day0 and Day90).
3 Change in Lipid Profile(Screening and Day90).
4 Change in anthropometric measurements(Baseline,Day30,Day60 and Day90).
5 Clinical Photographs(Screening and Day90). 
 
Secondary Outcome  
Outcome  TimePoints 
1 Adverse Events.
2 Serious Adverse Events.
3 Abnormal Vital Signs.
4 Abnormal Laboratory Investigations. 		 1 Adverse Events(Day30,Day60,Day90 and follow up).
2 Serious Adverse Events(Day30,Day60,Day90 and follow up).
3 Abnormal Vital Signs(Screening,Day0,Day30,Day60 and Day90).
4 Abnormal Laboratory Investigations(Screening and Day90). 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   11/04/2017 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A prospective, randomized, double blind, placebo controlled study in 36 adult male or female patients with BMI in the range of greater than equal to 35 to 40 kg/m2 will be conducted to evaluate the efficacy and safety of Curcuma caesia and Forskolin capsules. The individual subject participation will be for 90 days followed by a telephonic follow up visit. The efficacy assessments for the study are body weight, body mass index, DEXA, lipid profile, anthropometric measurements and clinical photographs. The safety assessments for the study are adverse or serious adverse events, vital signs and laboratory investigations. Statistical analysis will be performed as listed in the protocol. 
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