Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/04/2010
Date assigned
30/07/2010
Last edited
20/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Artatrana Misra

ORCID ID

Contact details

Department of General Medicine
Nagarjuna Hospital
Vijayawada
520007
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10-002/Ob/Sp

Study information

Scientific title

Comparative efficacy and tolerability of a novel botanical formulation LI12507F in the treatment and control of obesity: a randomised, double-blind placebo controlled clinical study

Acronym

Anti-obese Nutraceuticals

Study hypothesis

Supplementation of herbal formulations might be useful for management of body weight in obese human subjects.

Ethics approval

Internal Review Board of ASR Academy of Medical Sciences (India) approved on the 10th March 2010 (ref: ASRIRB-10-002)

Study design

Randomised double blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

A total 60 human subjects is randomised and divided into two groups:
1. LI12507F
2. Placebo

The treatment dosage is 800 mg daily, consisting of two 400 mg doses daily for the active group. Each subject included in the second group receives 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

Phase

Not Specified

Drug names

LI12507F

Primary outcome measures

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. Triglycerides
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 secondary outcomes will be measured on the baseline, and on 56th day.

Overall trial start date

14/03/2010

Overall trial end date

10/08/2010

Reason abandoned

Eligibility

Participant 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) greater 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 KCal 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 5 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:
11.1. Should be negative in pregnancy test
11.2. Should not be nursing
11.3. 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 postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Sixty participants

Participant 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

Recruitment start date

14/03/2010

Recruitment end date

10/08/2010

Locations

Countries of recruitment

India

Trial participating centre

Department of General Medicine
Vijayawada
520007
India

Sponsor information

Organisation

Laila Nutraceuticals (India)

Sponsor details

Unit-6 & 7
Phase-III
Jawahar Autonagar
Vijayawada
520007
India

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Laila Nutraceuticals (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23767862

Publication citations

  1. Results

    Stern JS, Peerson J, Mishra AT, Mathukumalli VS, Konda PR, Efficacy and tolerability of an herbal formulation for weight management., J Med Food, 2013, 16, 6, 529-537, doi: 10.1089/jmf.2012.0178.

Additional files

Editorial Notes