None listed
Conditions
Interventions
Intervention1: Sukumara Ghritam and Bramhi Churnam: These are classical Ayurvedic formulations mentioned in Ayurvedic formulary of India, published by Govt.of India.
1.Sukumara Ghritam
Dose: 12gms(6gm
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
Eligibility
Inclusion criteria
Inclusion criteria: (1)Females of age between 40 and 55 years. (2)Amenorrhoea for >= 12 months. (3)Kupperman menopausal index score >= 15. (4)FSH >= 20 IU/L. (5)Thickness of endometrial (6)Willing and able to participate for 16 weeks
Exclusion criteria
Exclusion criteria: (1)Patients with evidence of malignancy. (2)Surgical menopause. (3)Established cases of any mental illness. (4)Patients with diabetes mellitus HbA1C > 6.5% (5)Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) (6) Any unstable cardio-vascular diseases. (7) Patients with poorly controlled Hypertension (>= 160 /100 mm Hg) (8)Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics,hormone replacement therapy etc. or any other drugs that may have an influence on the outcome of the study. (9) Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and /or Alanine Amino Transferase (ALT) > 2 times upper normal limit or Renal Disorders (defined as S. creatinine > upper limit of Lab.value), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]) (10)Alcoholics and/or drug abusers. (11)H/o hypersensitivity to any of the trial drugs or their ingredients. (12) Patients who have completed participation in any other Clinical trial during the past six (06) months. (13) Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the clinical symptoms (using Menopause Rating Scale)Timepoint: 112th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in level of Serum Estradiol, S. Luteinizing Hormone, Follicular Stimulating Hormone [Time frame: At baseline & 12th week] ï??ï? Change in quality of Life by using Menopause Specific Quality of Life Questionnaire (MENQOL) [Time frame: At baseline, 12th and 16th week.] Timepoint: At baseline & 12th week At baseline, 12th and 16th week | — |
Countries
India
Contacts
Public ContactDr K Prameeladevi
Dr Achanta Lakshmipathi Research Centre for Ayurveda
Outcome results
None listed