A randomized clinical trial assessing efficacy and safety of Curcuma comosa extract on vasomotor symptoms

Phase 1

• Conditions: Hot flashes Safety; Curcuma comosa; Hotflashes; Safety; Menopause; Perimenopause; Climacteric symptoms

• Registration Number: TCTR20140818001
• Lead Sponsor: Agricaultural research development agency (Public organization)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-18
• Study Completion: 2015-09-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Women age 40 55 years with one of the followings
1 Perimenopause with no more than 1 month of menstruation within 3 months
2 Amenorrhea more than 12 months postmenopause
3 After bilateral oophorectomy with or without hysterectomy more than 6 weeks

Exclusion Criteria

1 Use hormone within 3 months before subject recruitment
2 Previous history of myocardial infarction or stroke within 6 months
3 Breast cancer or endometrial cancer within 5 years
4 Active thromoblebitis
5 Endometrial hyperplasia
6 Acute hepatitis
7 Abnormal renal function
8 insulinoma pheochromocytoma carcinoid syndromes leukemia pancreatic tumors autoimmune disorders and mast cell disorders
9 Current usage of tamoxifene raloxifene

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequecy and severity of hot fushes 1 and 4 month Count and rate severity of symptom

Secondary Outcome Measures

Name	Time	Method
renal and liver functions 1 and 4 month Blood test i.e. Elisa,Presence of abnormal findings at uterus and organ 1 and 4 month Ultrasond at lower abdoment,Vaginal maturation index 1 and 4 month Counting cells,Vaginal pH 1 and 4 month pH stripping testing