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CTRI Number  CTRI/2017/03/008045 [Registered on: 08/03/2017] Trial Registered Retrospectively
Last Modified On: 28/04/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   This is a double blind study where Curcuma caesia is compared to Placebo in weight management. 
Scientific Title of Study   A randomized, double blind, placebo controlled, clinical study to evaluate the efficacy and safety of Curcuma caesia for weight management in obesity. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPL/54/CCW/OCT/16V1.024-OCT-16  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Selvi 
Designation  General Physician 
Affiliation  Chennai Meenakshi Multispeciality Hospital 
Address  0ld No 148, New No 72, Luz Church Road, Mylapore, Chennai

Chennai
TAMIL NADU
600004
India 
Phone  04442938938  
Fax    
Email  researchchennaimeenakshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kiran Vuppala 
Designation  Senior Manager 
Affiliation  ClinWorld(P)Limited 
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  Mr Sanjib Panda 
Designation  Head Operations 
Affiliation  Ocius Life Sciences Private Limited 
Address  No 325, P H Road, Next to Pachaiyappas College, Aminijikarai, Chennai.

Chennai
TAMIL NADU
600029
India 
Phone  9003580729  
Fax    
Email  sanjib@ociuslife.com  
 
Source of Monetary or Material Support  
Sami Labs Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560 058. 
 
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 & manufacturer of phytonutrients, ayurvedic, herbal extracts, probiotics etc.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr H Praveen  Kakatiya Hospital  #12-52 Road No. 2, P & T Colony, Medipally, Hyderabad-500039. Telangana,India.
Hyderabad
ANDHRA PRADESH 		 9491820894

praveenkanjarla@gmail.com 
Dr M Selvi  Meenakshi Multispeciality Hospital  Department of General Medicine,Old # 148, New # 72,Luz Church Road,Mylapore, Chennai.600004.
Chennai
TAMIL NADU 		 04442938938

researchchennaimeenakshi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Chennai Meenakshi Multispeciality Hospital Ethics Committee  Approved 
Kakatiya Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adult male or female patients with BMI greater than equal to 35 to 40 kg/m2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcuma caesia  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  60.00 Year(s)
Gender  Both 
Details  1 Male and/or female patients.
2 Age between 20 to 60 years.
3 BMI between > 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/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Praderwilli syndrome).
3 Patients with evidence of malignancy.
4 Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, etc. or any other drugs that may have an influence on the outcome of the study.
5 Symptomatic patient with clinical evidence of Heart failure.
6 History of HIV and other viral infections.
7 Prior surgical therapy for obesity
8 History of hypersensitivity to any of the herbal extracts or dietary supplement.
9 Pregnant / lactating woman.
10 Patients who have completed participation in any other clinical trial during the past six (06) months.
11 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 Body weight and BMI.
2 Biomarkers.
3 Lipid Profile.
4 Anthropometric measurements.
5 Clinical Photographs.
6 QOL Questionnaire. 		 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5).
2 Biomarkers(Baseline & Final visit).
3 Lipid Profile(Screening & Final visit).
4 Anthropometric measurements(Baseline,Day30,Day60 & Day90).
5 Clinical Photographs(Screening & Final visit).
6 QOL Questionnaire (Baseline & Final visit). 
 
Secondary Outcome  
Outcome  TimePoints 
1 Adverse or serious adverse events.
2 Abnormal vital signs.
3 Abnormal lab investigations. 		 1 Adverse or serious adverse events(Day30,Day60 & Day90).
2 Abnormal vital signs(Screening,Day0,Day30,Day60 & Day90).
3 Abnormal lab investigations(Screening & Day90). 
 
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   Phase 2 
Date of First Enrollment (India)   12/01/2017 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 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 60 adult male or female patients with BMI in the range of 35 to 40 kg/m2 both inclusive will be conducted to evaluate the efficacy and safety of Curcuma caesia capsules. The individual subject participation will be for 90 days followed by a telephonic follow up visit. The primary assessments for the study are body weight, body mass index, biomarkers, lipid profile, anthropometric measurements, clinical photographs and quality of life questionnaire. The secondary assessments for the study are adverse events, abnormal vital signs and abnormal laboratory parameters. Statistical analysis will be performed as listed in the protocol. 
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