Anti-obesity activity of Leaf and stem bark of Mahanimba(Melia azedarach Linn.): In-silico, In-vitro and Exploratory clinical study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement in Objective (Weight, BMI, Body circumference, Lipid Profile, LFT) and subjective (Gradings) parameters
Study Overview
Brief Summary
INTRODUCTION
Obesity is a concern of public health. Overweight and obesity are lifestyle illnesses that contributes to numerous chronic diseases, including cancers, diabetes, metabolic syndrome, and cardiovascular diseases. Mahanimba is one such tree which is having Tikta and Kashaya rasa and which is well cited in ancient Ayurveda classics with wide indications i.e. Bhrma (giddiness), Chardi (vomiting), Kushta (skin diseases), Hrullas (nausea), Raktavikara , Prameha. These rasa are well cited for medohara action in our ancient texts. Botanically it is identified as Melia azedarach Linn. The tree has been evaluated for its in-vitro antiviral activity, anti-fungal activity, in vitro acaricidal activity, anti-oxidant activity, in-vivo antidiabetic and gastric inhibitory activity etc. but its anti-obesity effect in In-silico, in In-vivo and clinical is yet to be explored. Thus, the present study is taken under consideration.
HYPOTHESIS
Null hypothesis (H0):
Mahanimba leaf ghan vati and stem bark ghan vati does not have anti-obesity activity in In-silico, In-vitro (PL inhibitory assay), and in obese patients.
Alternate hypothesis (H1):
Mahanimba leaf ghan vati and stem bark ghan vati have anti-obesity activity in In-silico, In-vitro (PL inhibitory assay), and in obese patients.
END POINT
The patients will be assessed on the basis of basis of reduction in BMI by 1 unit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •BMI greater than 30 and less than equals to 40.
Exclusion Criteria
- •Patients having grade II and III hepatomegaly.
- •Patients having history of Diabetes Mellitus, PCOD, Thyroid disorders and uncontrolled Hypertension.
- •Pregnant females and lactating women.
- •Patients having simultaneous intake of Anticonvulsant, Beta-blockers, Corticosteroid.
- •Patients taking any other medicines for obesity.
- •Any study participants condition which is considered by the investigating team to jeopardize.
Outcomes
Primary Outcomes
Improvement in Objective (Weight, BMI, Body circumference, Lipid Profile, LFT) and subjective (Gradings) parameters
Time Frame: 0th day, 30th, 60th and 90th day
Secondary Outcomes
- • Change in Vitamin B12 levels.(• Comparative anti-obesity activity of leaf and stem bark of Mahanimba.)
Investigators
Dr Aman Singhal
All India Institute of Ayurveda