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.

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/m2 ([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