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Treatment of Nisyan (Amnesia) with Unani medicine Majun Boolus

An Open-Label, Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial Formulation â?? Majun Boolus in Nisyan (Amnesia)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034593
Enrollment
110
Registered
2021-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R411- Anterograde amnesia

Interventions

Intervention1: Majun Boolus: Majoon Bolus 5 g Twice daily Orally with water for 12 weeks Control Intervention1: NIL: NIL

Sponsors

Central Council for Research in Unani Medicine CCRUM New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patients fulfilling the following inclusion criteria will be included in this study: 1. Subjects of either sex in the age group 40-80 years. 2. Subjects with MMSE score of 10-23 representing mild to moderate cognitive impairment.

Exclusion criteria

Exclusion criteria: 1. Clinical presentation and/or history of any significant organic neurological diseases including space occupying lesions, stroke, head injury, seizure, and mental retardation 2. Subjects with impairment of speech, hearing and vision, which can impede the interview for MMSE and QOL assessment 3. Known cases of hypothyroidism or hyperthyroidism 4. Subjects with Vitamin B12 deficiency 5. Subjects on Psychotropic Drugs 6. Clinical presentation and/or history of a chronic disease that requires long-term treatment, e.g., DM, tuberculosis, HIV infection, syphilis, CVD, pulmonary disease, CKD, chronic liver disease, or any other serious and/or unstable medical condition that, in the opinion of the investigator, could expose the patients to undue risk of a significant adverse event or interfere with assessment of safety or efficacy during the course of the trial 7. Pregnant and lactating females 8. H/o Addiction (alcohol, drugs)

Design outcomes

Primary

MeasureTime frame
Improvement in sign and symptoms of Nisyan (Amnesia)Timepoint: The patients will be assessed at every 2 weeks. The total duration of treatment is 12 weeks. The results of the study will be recorded in terms of percentage efficacy as calculated from enhancement in the mini-mental status examination (MMSE) score and improvement in Quality of Life (QOL).

Secondary

MeasureTime frame
Haematological and biochemical assessment for safety assessmentTimepoint: 12weeks

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

ccrum507@rediffmail.com9213511298

Outcome results

None listed

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