Effect of Ayurvedic formulation Vidanga Churna and Vyoshadi Guggulu in the Management of Medoroga (Obesity)

Not Applicable

Completed

• Conditions: Health Condition 1: E669- Obesity, unspecified

• Registration Number: CTRI/2022/05/042681
• Lead Sponsor: Central council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-09-23
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

i)Obese subjects of BMI ( >25 to 39.9 kg/m2)

ii)Obese patients of either sex and of age between 18 – 45 years

iii)Willing to participate in the study

Exclusion Criteria

i)Obesity due to secondary causes – Hypothyroidism, PCOD,

Cushing’s syndrome etc.

ii)Patients with poorly controlled Hypertension

(BP > 160 / 100 mm Hg)

iii)Patients with uncontrolled Diabetes Mellitus having HbA1C >8%

iv)Patients who are on corticosteroids, Ca++ channel blockers,

Anti-psychotics, antidepressants, anti-cholinergic, anti-epileptics,

immune-suppressants, Hormonal replacement therapy or any

other drugs that may have an influence on outcome of study.

v)Patients with the H/O significant systemic illness which might

interfere with the compliance of the trail drug (Rheumatoid

arthritis, Tuberculosis, Inflammatory Bowel Disease etc.).

vi)Patients who have a past history of Cardiac Arrhythmia,

Acute Coronary Syndrome, Myocardial Infarction, Stroke

or Severe Arrhythmia in the last 6 months.

vii)Symptomatic patients with clinical evidence of congestive

cardiac failure.

viii)Known cases of HIV and AIDS &Patients suffering with malignancy.

ix) Patients with concurrent serious hepatic disorders (defined as

Aspartate Amino Transferase (AST) and / or Alanine Amino

Transferase (ALT) > 2 times upper normal limit) or Renal Disorders

(defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction

(uncontrolled Bronchial Asthma and / or Chronic Obstructive

Pulmonary Disease (COPD)

x) Women who are planning for conception / pregnant or lactating.

xi) H/o hypersensitivity to any of the trial drugs or their ingredients.

xii)Any other condition which the Investigator thinks may jeopardize

the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure: <br/ ><br>1. Changes in BMI <br/ ><br>2. Change in Waist circumference <br/ ><br>3. Mean change in body weight from base line <br/ ><br>4. Percentage of participants who achieve a minimum of 10% of weight loss.Timepoint: 1. Changes in BMI <br/ ><br>2. Change in Waist circumference will be assessed on 14th day 28th day, 42nd day, 56th day, 70th day, 84th day and 98th day. <br/ ><br>3. The Mean change in body weight from base line will be assessed.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure: <br/ ><br>1. Changes in percentage of body fat assessed by DEXA Scan. <br/ ><br>2. Change in Obesity Weight loss Quality of Life Instrument (OWL – QoL) <br/ ><br>3. Change in Lipid Profile <br/ ><br>4. Changes in HbA1cTimepoint: 84th day