TITLE

A long term observational surveillance study in obese patient already on tablet caralluma fimbriata extract 500 mg to assess the efficacy and safety in clinical practice.

Study Center

Gujarat Endocrine Centre

Objective (s)

To observe the efficacy and safety of tablet caralluma fimbriata extract 500 mg in patient with obesity for long-term  clinical use

Design

Open label, observational, prospective, single center, study

Study Population

Patients of either sex between 18 and 55 years of age suffering from obesity

Selection Criteria

Inclusion Criteria:

·         Patient willing to sign Inform Consent Form  (ICF)

·         Female patient not planning to conceive for 1 year during study period ( willing to use contraception during study period )

·         Either sex patient between 18 and 55 years of age

·         Body mass index ≥ 25-40  kg/m^{2 ([i])}

·         Already on tablet Caralluma Fimbriata extract 500 mg since last 1-30 days

·         Could understand the options offered and the study process

·         Patients who are willing to comply with the requirements of study

·         Patient willing for follow up for at least 1 year

Exclusion Criteria:

·         Patients with pregnancy and/or lactation

·         Patients going to plan pregnancy and/or lactation in next one year

·         Patient with certain diseases within the previous year; a history of depression, schizophrenia, anticoagulation problems, trauma, or surgery within 3 months of study commencement

·         Participation in another clinical trial within 1 month of the study.

·         Patient undergoing or who recently underwent coronary artery bypass graft (CABG) surgery.

·         Patient with history of myocardial infarction or stroke in last 2 years

·         Candidates with a history of bariatric surgery or medical problems that contraindicated treatment in either study group

·         Patient who has impaired mental status, drug or alcohol addiction, or portal hypertension

·         Patient who have demonstrated allergic-type reactions Caralluma fimbriata extract.

·         Patient with significant hepatic or renal insufficiency.

·         As deemed inappropriate for enrollment by investigating physician due to other reasons

Study Period

12 months per patient on observation divided in to 6  visits per patients (Screening visit, enrollment visit and follow up visits)

Study Endpoints

Efficacy:

Primary Outcome Measures:

·         Proportion of patients having  5% or more weight reduction from baseline and maintaining the same throughout the study period [ Time Frame: 1, 3, 6, 9,  and 12 months post baseline ]

·         Appetite suppression assessed on VAS scale using hunger as variable from baseline [ Time Frame: 1, 3, 6, 9,  and 12 months post baseline ]

Secondary Outcome Measures:

·         Reduction of body mass index (BMI) in Percentage and  reduction in waist circumference in Percentage [ Time Frame: 1, 3, 6, 9,  and 12 months post baseline ]

·         Improvement in body composition analysis  (BCA)

ü  Reduction in percentage of body fat [ Time Frame: 1, 3, 6, 9,  and 12 months post baseline ]

ü  Improvement in skeletal muscle percentage [ Time Frame: 1, 3, 6, 9,  and 12 months post baseline ]

Safety :  Safety evaluation will be based on -

·         Any adverse event reported voluntarily, observed or enquired during the study period

·         Any clinically significant change in the value of laboratory, vital signs and physical examination during the study compared to baseline.

Sample Size

200 patients at trial site

Statistical Plan

Data collected and compiled on paper CRFs will be acquired into the computer by data entry. Then the data will be analyzed by using appropriate statistical tests.

Study Dates (start/end)

As per IRB/IEC approval