Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Vyoshadi guggulu
Vidanga churna: Vyoshadi Guggulu Dose : 1 gm (2 Tablets of 500mg each) thrice daily Dosage form : Tablet Route of Administration : Oral Time of Admi
Sponsors
Central council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: 1. Changes in BMI 2. Change in Waist circumference 3. Mean change in body weight from base line 4. Percentage of participants who achieve a minimum of 10% of weight loss.Timepoint: 1. Changes in BMI 2. Change in Waist circumference will be assessed on 14th day 28th day, 42nd day, 56th day, 70th day, 84th day and 98th day. 3. The Mean change in body weight from base line will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measure: 1. Changes in percentage of body fat assessed by DEXA Scan. 2. Change in Obesity Weight loss Quality of Life Instrument (OWL – QoL) 3. Change in Lipid Profile 4. Changes in HbA1cTimepoint: 84th day | — |
Countries
India
Contacts
Public ContactDr Sulochana Bhat
Regional Ayurveda Research Institute for Metabolic Disorders(RARIMD)
Outcome results
None listed