None listed
Conditions
Interventions
Intervention1: Brahma Rasayan: Drug : Brahma Rasayan
Dose : 15 g BD
Route of Administration : Oral
Anupana : Luke warm milk
Duration of Therapy : 12 Weeks
Study Design
Level of study : OPD level onl
Sponsors
CCRAS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Criteria for Inclusion : 1.Apparently Healthy Male/ Female on clinical examination of age between 50-75 years. 2.Patients complaining of general weakness and other vague complaints not including the involvement of any particular system. 3.Willing to participate
Exclusion criteria
Exclusion criteria: 1.Patients with evidence of malignancy 2.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-endocrinal disorder etc). 3.Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD) Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 4.Symptomatic patient with clinical evidence of Heart failure. 5.Uncontrolled Hypertensive (taking more than two drugs) 6.Patients on Prolonged ( >6 weeks) medication with corticosteroids, antidepressants, anticholinergics etc. or any other drugs that may have an influence on the outcomes of the study. 7.Patients with concurrent serious hepatic disorder (defined as Aspatate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit or Renal Disorder (defined as S. Creatinine > 1.2 mg/dL). 8. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD), Inflammatory Bowel Disease, Serve Dementia, Severe Infection(s), Non-ambulatory patients or nay other condition that may jeopardize the study. 9.Prostate Specific Antigen (PSA) level >4 ng/mL. 10.Alcoholics and/ or drugs abusers. 11.Pregnant/ lactating womenâ??s 12.Patients suffering from uncontrolled Diabetes {HbAlc >9%) 13.HIV positive subjects. 14.H/o hypersensitivity to the trial drug or any of its ingredients. 15.Patients who have complete participation in nay other clinical trial during the past (06) months. 16.Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Clinical Symptom (using the visual analogue scale) 2. Change in Quality of Life using WHOQOL-BREF Timepoint: 1. At base line 14th days, 28th days, 42nd days, 56th days, 70th days and end of the 84th days. 2. At base line 28th days, 56th days and end of the 84th days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures : 1. Change in Hamiliton Depression Rating Scale (HAM-D) 2. Change in PGI Memory Scale 3. Change in the Laboratory parameter like ESR, Serum cholesterol, HDL, LDL, CRP, TSH, Serum Vitamin D3, Serum Ca. Timepoint: 1. At base line 28th days, 56th days at the end of 84th days. 2. At base line 28th days, 56th days at the end of 84th days. 3. At base line end of 84th days. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed