This is a double blind study where Curcuma caesia is compared to Placebo in weight management.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/03/008045
• Date of registration: 08-03-2017
• Prospective Registration: No
• Primary sponsor: Sami Labs Limited
• Public title: This is a double blind study where Curcuma caesia is compared to Placebo in weight management.
• Scientific title: A randomized, double blind, placebo controlled, clinical study to evaluate the efficacy and safety of Curcuma caesia for weight management in obesity.
• Date of first enrolment: 12-01-2017
• Target sample size: 60
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17073
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Mr Kiran Vuppala
• Affiliation: ClinWorld(P)Limited

• Name: Mr Sanjib Panda
• Affiliation: ClinWorld(P)Limited

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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 (Cushingâ??s syndrome, Turnerâ??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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Adult male or female patients with BMI greater than equal to 35 to 40 kg/m2

Intervention(s)

Intervention1: Curcuma caesia: One capsule twice a day for 90 days.
Control Intervention1: Placebo: One capsule twice a day for 90 days.

Primary Outcome(s)

1 Body weight and BMI.

2 Biomarkers.

3 Lipid Profile.

4 Anthropometric measurements.

5 Clinical Photographs.

6 QOL Questionnaire.Timepoint: 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(s)

1 Adverse or serious adverse events.

2 Abnormal vital signs.

3 Abnormal lab investigations.Timepoint: 1 Adverse or serious adverse events(Day30,Day60 & Day90).

2 Abnormal vital signs(Screening,Day0,Day30,Day60 & Day90).

3 Abnormal lab investigations(Screening & Day90).

Secondary ID(s)

CPL/54/CCW/OCT/16V1.024-OCT-16

Source(s) of Monetary Support

Sami Labs Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560 058.

Ethics review

Status: Approved
Approval date: 09/02/2017
Contact:

Chennai Meenakshi Multispeciality Hospital Ethics Committee

Status: Approved
Approval date: 31/03/2017
Contact:

Kakatiya Hospital Ethics Committee