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Clinical Trials/CTRI/2015/11/006333
CTRI/2015/11/006333
Not yet recruiting
Phase 2

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE ROLE OF DIET THERAPY AND VYOSHADI SAKTU IN OBESITY

Government Ayurveda Medical college Mysore0 sites60 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Government Ayurveda Medical college Mysore
Enrollment
60
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Government Ayurveda Medical college Mysore

Eligibility Criteria

Inclusion Criteria

  • •Elevated levels of lipid profile
  • •BMI between \>30 to 40kg/m2
  • •Willing to come for regular follow\-up visits
  • •Able to give written information consent

Exclusion Criteria

  • •Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months
  • •Pathophysiological/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader willi syndrome)
  • •Patients with evidence of malignancy
  • •Patients with poorly controlled Diabetes Mellitus (HbA1c \> 10%)
  • •Patients with poorly controlled Hypertension ( \>160/100 mm Hg)
  • •Patients on prolonged ( \> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study
  • •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho\-Neuro\-Endocrinal disorders etc.)
  • •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infraction, Stroke or Severe Arrhythmia in the last 6 months
  • •Symptomatic patient with clinical evidence of Heart failure.
  • •Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) \> 2\.5 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), or any other condition that may jeopardize the study.

Outcomes

Primary Outcomes

Not specified

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