To study the effect of Tab HFO-O2 in fatty individuals.

Completed

Conditions: Human volunteers with a BMI between 25 and 30 are to be recruited

Registration Number: CTRI/2016/07/007067

Lead Sponsor: Baidyanath Bhavan Pvt Ltd

Brief Summary: The primary purpose of the study is to evaluate the clinical efficacy of Tab. HFO-O2 in overweight individuals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 12

Inclusion Criteria

1.Overweight individuals (Body Mass Index between 25-30) with controlled co-morbid dyslipidemia and/or hypertension and/or type 1 or type 2 diabetes 2.Stable body weight (less than 5 kg self-reported change during the previous 3 months) 3.Age between 18 years and 60 years 4.Individuals found compliant based on the Million Behavioural Medicine Diagnostic (MBMD) 5.Willing to give Informed consent before any trial-related activity takes place.

Exclusion Criteria

1.Known case of endocrinological disorders such as hyper/hypo thyroidism, Poly Cystic Ovarian Syndrome (PCOS) 2.History of use one month before screening /currently using Allopathic or Ayurvedic medicines that may cause significant weight gain 3.History of use one month before screening /currently using dietary supplements, over-the-counter medications or below mentioned Allopathic /Ayurvedic medicines for weight loss 4.Current participation (past one month) in an organized weight reduction program â€ƒ 5.Participants with a history of major depressive or other severe psychiatric disorders or an eating disorder [judged by frequency and quantity of food] 6.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator 7.Pregnant or lactating females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome of the study will be measured in terms of anthropometric measurements (Weight, Body Mass Index, Waist Hip Ratio, Circumferences, Skinfold thicknesses)and Clinical signs and symptoms.	After every 15 days

Secondary Outcome Measures

Name	Time	Method
The secondary outcome of the study will be measured on the basis of biochemical profiling of obesity markers.	Day 0,Day 30,Day 60,Day 90, Day 120

Trial Locations

Locations (1): College of Ayurved, BVDU
🇮🇳
Pune, MAHARASHTRA, India
College of Ayurved, BVDU
🇮🇳Pune, MAHARASHTRA, India
Dr Supriya Bhalerao
Principal investigator
9527589516
supriya.bhalerao@gmail.com