A clinical trial to study the effect of dietary supplementation of Flax Seeds on signs and symptoms associated with Perimenopausal Syndrome

Efficacy of dietary intervention of Flaxseeds(Linum usitatissimum) on signs and symptoms associated with Perimenopausal Syndrome

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045980

Enrollment

120

Registered

2022-09-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N959- Unspecified menopausal and perimenopausal disorder

Interventions

Intervention1: Flaxseeds 10gm OD for 3 months : Treatment group will be given 10gm ground flaxseed powder daily up to 3 months Control Intervention1: Roasted Wheat Flour 10gm OD for 3 months: Placebo

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Significant Changes in menopausal symptom score according to Modified Kuppermans Index Score greater than 6 Menopause Rating Scale greater than 4 MENQOL Intervention questionnaire score assessment Timepoint: Significant changes in menopausal symptom score Modified Kuppermans Index Score at Baseline,12 weeks Menopause Rating Scale at baseline, 12 weeks MENQOL Intervention questionnaire score at baseline, 12 weeks	—

Measure

Time frame

Significant Changes in menopausal symptom score according to Modified Kuppermans Index Score greater than 6 Menopause Rating Scale greater than 4 MENQOL Intervention questionnaire score assessment Timepoint: Significant changes in menopausal symptom score Modified Kuppermans Index Score at Baseline,12 weeks Menopause Rating Scale at baseline, 12 weeks MENQOL Intervention questionnaire score at baseline, 12 weeks

—

Secondary

Measure	Time frame
Levels of lignans and hormones before and after dietary intervention Enterolactone (ENL) Enterodiol (END) Estradiol hormoneTimepoint: Enterolactone (ENL) timepoint- at baseline, 12 weeks Enterodiol (END) Timepoint- at baseline, 12 weeks Estradiol hormone Timepoint- at baseline, 12 weeks	—

Countries

India

Contacts

Public ContactRashmi Shrivastava

King George Medical University, Lucknow

narsinghverma@gmail.com9839064560

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026