To evaluate the Safety and efficacy of Unani formulation Itrifal Muqawwi Dimagh in NisyÄ?n (Amnesia)
- Conditions
- Health Condition 1: null- NisyÄ?n (Amnesia)Health Condition 2: R413- Other amnesia
- Registration Number
- CTRI/2015/12/006430
- Lead Sponsor
- Central Council for Research in Unani Medicine New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 300
The patients fulfilling the following criteria will be included in this study:
•Patients of either sex in the age group 40-65 years.
•Patients of NisyÄ?n (Amnesia) having:
ï?§Subjective complaints of memory problems
ï?§MMSE score of 10-24 representing mild to moderate cognitive impairment
The patients having any of the following criteria will be excluded from the study:
1.Clinical presentation and/or history of any organic neurological disease which interferes with the function of limbic system.
2.Known cases of hypothyroidism or hyperthyroidism.
3.Vitamin B12 deficiency
4.Patients on Psychotropic Drugs
5.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.
6.Pregnant and lactating women
7.H/o Addiction (alcohol, drugs)
8.H/o Hypersensitivity to the study drug or any of its ingredients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome TimePoints <br/ ><br>improvement in the sign and symptoms of NisyÄ?n (Amnesia)Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Hematological and biochemical assessments for safetyTimepoint: 12 weeks