Treatment for Menopausal syndrome

Phase 4

• Registration Number: CTRI/2017/11/010312
• 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
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 <= 5 mm

(6)Willing and able to participate for 16 weeks

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the clinical symptoms (using Menopause Rating Scale)Timepoint: 112th Day

Secondary Outcome Measures

Name	Time	Method
Change in level of Serum Estradiol, S. Luteinizing Hormone, Follicular <br/ ><br>Stimulating Hormone [Time frame: At baseline & 12th week] <br/ ><br> <br/ ><br>ï??ï? Change in quality of Life by using Menopause Specific Quality of Life <br/ ><br>Questionnaire (MENQOL) [Time frame: At baseline, 12th and 16th week.] <br/ ><br>Timepoint: At baseline & 12th week <br/ ><br>At baseline, 12th and 16th week <br/ ><br>