Comparative efficacy and tolerability of a novel botanical extract LI 12508 and its formulation LI 12507F in the treatment and control of obesity
| ISRCTN | ISRCTN45078827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45078827 |
| Secondary identifying numbers | 09-006/Ob/Sp |
- Submission date
- 08/03/2010
- Registration date
- 30/07/2010
- Last edited
- 20/01/2014
- 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 Himanshu Dash
Scientific
Scientific
Department of General Medicine
ASR Academy of Medical Sciences
Eluru
534002
India
Study information
| Study design | Randomised double blind placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparative efficacy and tolerability of a novel botanical extract LI 12508 and its formulation LI 12507F in the treatment and control of obesity: a randomised, double-blind placebo controlled clinical study |
| Study acronym | Anti-obese nutraceuticals |
| Study objectives | Supplementation of herbal formulations might be useful for management of body weight in obese human subjects. |
| Ethics approval(s) | Internal Review Board of ASR Academy of Medical Sciences (India) approved on the 10th February 2010 (Ref: ASRAMIRB 09006) |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | A total 60 human subjects will be randomised and divided into three groups: 1. LI-12508 2. LI-12507F 3. Placebo The treatment dosage is 800 mg daily, consisting of two 400 mg doses daily for the active groups. Each subject included in the third group is receiving matched placebo per day. The study duration will be of 56 days. The visits and the evaluations are 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) | LI 12508, LI 12507F |
| 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. Adiponectin 3. Ghrelin The primary and secondary outcomes will be measured on baseline, 14th day, 28th day and 56th day. |
| Overall study start date | 07/03/2010 |
| Completion date | 07/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Participants must understand the risks and benefits of the study 2. Adults ages 21 - 50 years, either sex 3. Body mass index (BMI) less than 30 kg/m^2 4. Willingness to participate in an exercise-walking program, supervised by a trained exercise specialist 5. Willingness to consume the prescribed study diet of approximately 2,000 K Cal per day as outlined in the protocol (meals will be provided at free of cost by the study sponsor) 6. Ability to provide written informed consent for participation in the trial 7. Willingness to complete standard health history questionnaire before induction into the study 8. Willingness to participate in five clinic visits (Screening, baseline, 2, 4 and 8 weeks) 9. Subject willing to participate in health exercise program (30 minutes walking) monitored by the study physical trainer 10. Subjects must be instructed to abstain from alcoholic products during the study 11. If female, patients: 11.1. Should be negative in pregnancy test 11.2. Should not be nursing 11.3. 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., or post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) |
| Key exclusion criteria | 1. History of thyroid disease or cardiovascular disease or diabetes (uncontrolled) 2. Subjects having chronic diarrhoeal disorders, cancer, neurological disorders, hepatic dysfunction 3. Respiratory tract infection and other serious medical respiratory illnesses (i.e., chronic obstructive pulmonary disease [COPD], sarcoidosis) 4. History of allergy to spices and herbal products 5. Intractable obesity or uncontrolled body weight, BMI greater than 40 kg/m^2 6. Non-obese (BMI less than 30 kg/m^2) and morbidly obese (BMI greater than 40 kg/m^2) 7. Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss 8. Pregnant or nursing or lactating females 9. Recent, unexplained weight loss or gain 10. Women with a positive pregnancy test 11. Human immunodeficiency virus (HIV) or other known immunodeficiency 12. Undergone surgery before 30 days of screening or planning to undergo surgery within the study days 13. History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis 14. History of motor weakness or peripheral sensory neuropathy 15. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations |
| Date of first enrolment | 07/03/2010 |
| Date of final enrolment | 07/06/2010 |
Locations
Countries of recruitment
- India
Study participating centre
Department of General Medicine
Eluru
534002
India
534002
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 | 01/06/2013 | Yes | No |
