Flavinergy (extract of Black-Thai Ginger) on metabolic health of overweight adults

A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of Flavinergy on metabolic health of overweight adults. - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058149

Enrollment

Registered

2023-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

None listed

Interventions

Intervention1: Flavinergy: Extract of Black- Thai Ginger in capsule form with dose of 150 mg twice a day after breakfast and dinner for 90 days. Control Intervention1: Placebo: Microcrystalline Cellul

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants should be willing to give signed written informed consent. 2. Participants should be willing to comply with the requirements of the trial/study. 3. Male and Female participants aged between 25-55 years. 4. Subjects whose BMI lie between 25 to 29.99 kg/m2. 5. Subjects who meet any of the two criteria to be included in the study: a) Triglyceride more than 160mg/dl b) HDL Cholesterol less than 50 mg/dl in women and less than 40 mg/dl in men c) LDL Cholesterol more than 120 mg/dl d) Serum Total Cholesterol more than 200 mg/dl 6) Blood Pressure more than 130/90 mmHg without medication. 7) Fasting Blood Glucose more than 120 mg/dl without medication. 8) Ability to swallow and retain oral medications as per the protocol.

Exclusion criteria

Exclusion criteria: 1. Subjects who are taking any anti-obesity medication or weight reduction treatments including the herbal preparations. 2. Subjects with abnormal thyroid profile. 3. History of surgical procedures for weight loss. 4. Use of supplements, special diet or functional foods affecting carbohydrate and lipid metabolism during the study period. 5. History of chronic smoking and alcoholism. 6. Pregnant, lactating women and those not willing to follow a reliable and effective contraceptive measure during the study period.

Design outcomes

Primary

Measure	Time frame
1. Change in Visceral fat area. 2. Change in lipid profileTimepoint: 1. Change in Visceral fat area from day-1 to day-90. 2. Change in lipid profile from screening to day-90.	—

Secondary

Measure	Time frame
1. Change in Body weight & BMI. 2. Mean change in Anthropometric measurement 3. Change in Sub-cutaneous fat area and Total fat area. 4. Improvement in Blood Pressure and Fasting Blood Glucose. 5. Safety is determined based on the tolerance to Flavinergy without any incidence of adverse events. Study compliance without drop-outs. No adverse change in complete blood count, urine routine and microscopic blood biochemistry, and incidence of any adverse events during the study period in both the arms.Timepoint: 1. Screening to Day-90 2. Screening to Day-90 3. Day-1 to Day-90 4. Screening to Day-90 5. Day-1 to Day-90	—

Measure

Time frame

1. Change in Body weight & BMI. 2. Mean change in Anthropometric measurement 3. Change in Sub-cutaneous fat area and Total fat area. 4. Improvement in Blood Pressure and Fasting Blood Glucose. 5. Safety is determined based on the tolerance to Flavinergy without any incidence of adverse events. Study compliance without drop-outs. No adverse change in complete blood count, urine routine and microscopic blood biochemistry, and incidence of any adverse events during the study period in both the arms.Timepoint: 1. Screening to Day-90 2. Screening to Day-90 3. Day-1 to Day-90 4. Screening to Day-90 5. Day-1 to Day-90

—

Countries

India

Contacts

Public ContactSatish G

Sami Sabinsa Group Limited

satish.g@clinworld.net08068527777

Outcome results