A clinical study to evaluate the efficacy of Herbal extract formulation in managing Obesity

A pilot study to evaluate the safety and efficacy of Murraya koenigii (Herbal Extract Formulation) in the management of Obesity - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093174

Enrollment

Registered

2025-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E669- Obesity, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects of any gender in the age group of 18-60 years 2.Subjects willing to provide written informed consent. 3.Subjects with BMI greater than or equal to 30 and Waist-Hip Ratio greater than 0.85 in female and greater than 0.90 in male

Exclusion criteria

Exclusion criteria: 1. Patients on any medications including Statins that are known to influence weight and/or lipids within the last 3 months. 2. Patient using the medications as systemic corticosteroids (nasal and inhaled corticosteroids are permitted), drugs such as thiazides, Anti-depressants, anti-anxiety, mood stabilizers beta-blockers, retinoids, highly active antiretroviral agents, cyclosporine, tacrolimus, estrogen and progestins, and glucocorticoids, bile acid resins, prescription omega-3 fatty acids, cyclical or non- continuous hormone therapy (estrogen or testosterone) excepted stable oestroprogestative or progestative contraception i.e. started at least three months preceding the screening visit, Patient taking antioxidant agents within 6 weeks prior to screening. 3. Patients with history of hepatic dysfunction (elevation in AST or ALT of greater than 2 times the laboratory reference) 4. Renal dysfunction 5. Known cases of uncontrolled Diabetes mellitus Glycosylated hemoglobin 8 percentage or greater. 6. Uncontrolled hypertension sitting BP greater than or equal to160 systolic or greater than or equal to 100 mmHg diastolic 7. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or not willing to use effective contraceptive precautions during the study. 8. Known cases of Smoking, drug abuse and alcoholism

Design outcomes

Primary

Measure	Time frame
Assessment of safety is through the changes in CBC, LFT and RFT before and after treatment with interventionTimepoint: Day 1 and Day 90	—

Secondary

Measure	Time frame
? Change in parameters of Lipid profile (LDL, Total Cholesterol, HDL, Triglycerides, VLDL), HbA1c [Time Frame: Baseline, 90th day] ? Changes in the atherogenic indices viz. Atherogenic index of plasma (AIP), Castelli Risk Index I and II (CRI), atherogenic coefficient (AC), and non-high density lipoprotein cholesterol (non- HDLc) (NHC), [Time Frame: Baseline, 90th day]. ? Change in IWQOL-Lite-CT Timepoint: [Time Frame: Baseline, 90th day]	—

Measure

Time frame

? Change in parameters of Lipid profile (LDL, Total Cholesterol, HDL, Triglycerides, VLDL), HbA1c [Time Frame: Baseline, 90th day] ? Changes in the atherogenic indices viz. Atherogenic index of plasma (AIP), Castelli Risk Index I and II (CRI), atherogenic coefficient (AC), and non-high density lipoprotein cholesterol (non- HDLc) (NHC), [Time Frame: Baseline, 90th day]. ? Change in IWQOL-Lite-CT Timepoint: [Time Frame: Baseline, 90th day]

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Countries

India

Contacts

Public ContactDr Sanjay M Jachak

NIPER, Mohali

sanjayjachak@niper.ac.in9888235595

Outcome results