Effect of Pyridoxine and Ascorbic acid on Mild Cognitive Impairment in Post-Menopausal Women

A Comparative Study on Effect of Pyridoxine and Ascorbic Acid on Mild Cognitive Impairment in Post-Menopausal Women

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/051131

Enrollment

180

Registered

2023-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: G319- Degenerative disease of nervous system, unspecified

Interventions

Intervention1: Pyridoxine (Vitamin B6): 25 mg pyridoxine once daily for 6 months Control Intervention1: Ascorbic Acid (Vitamin C): 100 mg ascorbic acid once daily for 6 months Control Intervention2: N

Eligibility

Inclusion criteria

Inclusion criteria: 1. MoCA Score 18-25 2. Menopausal women (taken as complete cessation of menstruation for at least 1 year/12 cycles)

Exclusion criteria

Exclusion criteria: 1. History of recent or current Estrogen or hormonal replacement therapy 2. Known hypertensive, diabetic, renal disease, endocrine disorders, overt nutritional deficiency states, liver disease or those having history of psychiatric illness. 3. History of Women having estrogen secreting ovarian tumors, for e.g., granulosa and theca cell tumors, tumors of the adrenal gland. 4. Known history of neurological disorders including CVA, space occupying lesions, epilepsy and developmental anomalies. 5. Women, who are physically unable to hear, read or understand written or explained instructions properly, or may have a motor deficit that affects writing and drawing skills. 6. Women, who are already in any of the antioxidant or dietary supplement therapy.

Design outcomes

Primary

Measure	Time frame
To determine the cognitive function of post-menopausal women using Montreal Cognitive Assessment (MoCA) scale. To determine the effectiveness of pyridoxine and ascorbic acid in the improvement of cognition rate using the measurement of biomarkers such as serum beta amyloid 42 and homocysteine. Timepoint: Baseline 6th month 12th month	—

Secondary

Measure	Time frame
To check the association between serum estradiol level measured at baseline with MoCA score. To evaluate the reproductive factors associated with cognitive decline. To assess the quality of life using Menopause Specific Quality of Life Questionnaire (MENQOL) before and after treatment. To assess the medication adherence using Medication Adherence Rating Scale (MARS), pill count method and refill rate Timepoint: Serum estradiol level will be measured at baseline The MoCA score will be evaluated at baseline, 3rd month, 6th month, 9th month and 12th month QoL will be analysed before and after treatment using MENQOL questionnaire	—

Measure

Time frame

To check the association between serum estradiol level measured at baseline with MoCA score. To evaluate the reproductive factors associated with cognitive decline. To assess the quality of life using Menopause Specific Quality of Life Questionnaire (MENQOL) before and after treatment. To assess the medication adherence using Medication Adherence Rating Scale (MARS), pill count method and refill rate Timepoint: Serum estradiol level will be measured at baseline The MoCA score will be evaluated at baseline, 3rd month, 6th month, 9th month and 12th month QoL will be analysed before and after treatment using MENQOL questionnaire

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Countries

India

Contacts

Public ContactDr S Sarumathy

PM Medical Centre

drmanigandan1988@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026