A clinical trial to study the effect of dietary supplementation of Flax Seeds on signs and symptoms associated with Perimenopausal Syndrome
Phase 2
- Conditions
- Health Condition 1: N959- Unspecified menopausal and perimenopausal disorder
- Registration Number
- CTRI/2022/09/045980
- Lead Sponsor
- Indian Society of Chronomedicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Subjects according to the guidelines of Indian
Menopause Society, FSH level should be >20 IU/ml with Vasomotor symptoms even in the absence of cessation of menstruation
2)Age should be between 40 to 55 years
3)Not under medication (estrogen and phytoestrogen)
Exclusion Criteria
1) Surgical menopause, hysterectomy, abnormal anatomical structures of the uterus or ovaries
2) Use of HRT, SSRIs (selective serotonin reuptake inhibitors)
3) History of malignancy, mental disorders including depression), thyroid diseases
4) With heart, liver or kidney diseases
5) Use of sedative or anti-anxiety drugs, Cigarette smoking, alcohol or drug abuse
6)Participation in other clinical trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method