Efficacy of three nutraceutical products of herbal origin in weight management of obese human subjects: a randomised, double blind, placebo controlled clinical study
| ISRCTN | ISRCTN37381706 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37381706 |
| Secondary identifying numbers | 07/001/PHF Ob |
- Submission date
- 14/11/2007
- Registration date
- 22/11/2007
- Last edited
- 28/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Artatrana Mishra
Scientific
Scientific
Department of General Medicine
ASR Academy of Medical Sciences
Eluru
534 002
India
Study information
| Study design | This is a randomised, double blind, placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Anti-obese Nutraceuticals |
| Study objectives | Public Title: Clinical efficacy of three nutraceutical products of herbal origin in obese subjects Supplementation of three natural polyherbal formulations will be helpful for management of weight control in obese human subjects. |
| Ethics approval(s) | Ethics approval received from the Internal Review Board of ASR Academy of Medical Sciences (India) on the 5th October 2007 (ref: 07-01/IB/PHF Ob). |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | A total of 100 human subjects is randomised and divided into four groups: 1. Adipolean 2. Adipolite 3. Betelean 4. Placebo The treatment dosage is 1500 mg day, consisting of three 500 mg doses daily for the active treatment groups. Each subject in the fourth group will receive color matched equal amount of placebo per day. The study duration will be 56 days. The visits and the evaluations will be at the baseline, 14th day, 28th day, and the 56th day. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Adipolean, Adipolite, Betelean |
| Primary outcome measure | 1. Physical/anthropometric parameters: 1.1. Body weight 1.2. Body mass Index 1.3. Waist hip ratio 2. Biochemical parameters (serum/plasma): 2.1. Fasting glucose 2.2. Fasting insulin 2.3. Triglyceride 2.4. Cholesterol 2.5. High Density Lipoprotein (HDL) cholesterol 2.6. Low Density Lipoprotein (LDL) cholesterol The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day. |
| Secondary outcome measures | Obesity biomarkers (serum/plasma): 1. Leptin 2. Glucagon like peptide-1 3. Adiponectin 4. Ghrelin The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day. |
| Overall study start date | 15/11/2007 |
| Completion date | 20/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Adults aged 21 - 50 years 2. Body Mass Index (BMI) greater than or equal to 30 kg/m^2 3. Willingness to participate in an exercise-walking program, supervised by a trained exercise specialist 4. Willingness to consume the prescribed study diet of approximately 2,000 KCal per day as outlined in the protocol (meals will be provided at free of cost by the study sponsor) 5. Written informed consent to participate in the trial 6. Willingness to complete standard health history questionnaire before induction into the study 7. Willingness to participate in five clinic visits (screening, baseline, 2, 4 & 8 weeks) 8. If female: 8.1. Should be negative in pregnancy test 8.2. If of childbearing potential, should agree to follow an acceptable method of birth control for the duration of the study, such as condoms, foams, jellies, diaphragm, Intrauterine Device (IUD), etc. 8.3. Postmenopausal for at least 1 year 8.4. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) |
| Key exclusion criteria | 1. History of thyroid disease or cardiovascular disease or diabetes 2. Any other clinically significant disorder 3. History of allergy to spices and herbal products 4. Intractable obesity or uncontrolled body weight, BMI greater than 40 kg/m^2 5. Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss 6. Recent, unexplained weight loss or gain 7. Positive Human Immunodeficiency Virus (HIV) test 8. History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis 9. History of motor weakness or peripheral sensory neuropathy 10. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations |
| Date of first enrolment | 15/11/2007 |
| Date of final enrolment | 20/01/2008 |
Locations
Countries of recruitment
- India
Study participating centre
Department of General Medicine
Eluru
534 002
India
534 002
India
Sponsor information
Laila Nutraceuticals (India)
Industry
Industry
Unit-6 & 7
Phase-III
Jawahar Autonagar
Vijayawada
520007
India
"ROR" |
https://ror.org/05q6g7072 |
|---|
Funders
Funder type
Industry
Laila Nutraceuticals (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/09/2012 | Yes | No |
