Efficacy of Ayurveda formulation in Post Menopausal Syndrome.

Phase 3

• Conditions: Health Condition 1: N951- Menopausal and female climactericstates

• Registration Number: CTRI/2022/06/043245
• 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: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Women of age between 40 to 59 years with history of spontaneous amenorrhoea for � 12 months and post menopausal climacteric symptoms

2. Modified Kupperman menopausal index weighted score 7 or more.

3. Willing and able to participate in the study for 4 months and ready to provide informed written consent.

Exclusion Criteria

1. History of hysterectomy or bilateral oophrectomy with or without hysterectomy

2. Known case of malignancy (cured or with ongoing treatment), ovarian cyst, endometriosis, any benign growth in the reproductive system, abnormal thyroid function, hypoglycemia carcinoid, or pheochromocytoma

3. History of post coital bleeding or any significant vaginal discharges or other symptoms arising suspicion of malignancy

4. Patients on prolonged ( > 6 weeks) medication like corticosteroids, antidepressants, anticholinergics, hormone replacement therapy etc. or any other chronic disorder or medication that may have an influence on the outcome of the study

5.Known cases of co-morbidities like uncontrolled diabetes mellitus (HbA1c >8%), uncontrolled hypertension (BP� 160/100 mm Hg), Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), pulmonary obstructive disorders, Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit), cardiac dysfunction or Immuno-compromised states like HIV

6. Alcohol or drug dependency (AUD) (CAGE score >2)

7. Known hypersensitivity to the study drug ingredient

8. Patients who have participated in any interventional study currently or have completed participation in any other clinical trial during the past three months since the day of screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants showing at least 7 point improvement in the score of Menopausal Rating Scale (MRS) in both groups.Timepoint: At Baseline,90th day and 120th day

Secondary Outcome Measures

Name	Time	Method
1. Change in serum estradiol level <br/ ><br>2. Change in Follicle stimulating hormone level <br/ ><br>3. Change in Menopause specific Quality of Life (MENQoL) score in both groups <br/ ><br>4. Change in hematological (complete blood count) and biochemical parameters (Liver function test and renal function tests) <br/ ><br>5. Incidence of treatment emergent adverse events <br/ ><br>Timepoint: 1. At baseline and 90th day <br/ ><br>2. At baseline and 90th day <br/ ><br>3.At Baseline,90th day and 120th day <br/ ><br>4.At baseline and 90th day <br/ ><br> <br/ ><br> <br/ ><br>