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临床试验/CTRI/2024/08/072293
CTRI/2024/08/072293尚未招募2 期

A randomized controlled clinical trial to study the effect of brahmi churna in smrutibransha with special reference to senile dementia

Dr Snehal Wasekar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月17日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Improvement in score of minimental state examination and sign and symptoms of smruthibhransha

研究概览

简要总结

-     Smruti is the remembrance of things by concentrated mind, directly perceived, heard or experienced earlier. If the person is not able to grasp or retain the present events or experiences, it is known as ‘Smrutivibhransa’. When the mind of any person is covered by the Rajasa and Moha its activities are being taken to such an extent that one cannot be able to recollect the memory stored as it is related to Tatvagyana. This condition is termed as ‘Smrutibransha’ which can be correlated with Senile Dementia in modern science. Dementia is a chronic organic mental disorder, characterized by progressive usually irreversible, global cognitive deficit. It is a condition in which one’s thinking and remembering ability gradually hampers. The estimated Senile dementia prevalence for adults ages 60 above in India is 7.4%. Brahmi Churna has been selected as it is tiktarasatmak, laghugunatmak, sheetvirya , madhuraviryatmak ,vaatpittaharka , medhya rasayan. It primarily either acts via antioxidant mechanism (i.e., neuroprotection) or alters different neurotransmitters (serotonin (5-hydroxytryptamine, 5-HT), dopamine (DA), acetylcholine (ACh), γ-aminobutyric acid (GABA)) to execute the pharmacological effect. The patients within the age group of 60-80 years who fulfill the clinical assessment criteria for senile dementia & having symptoms of Smrutibransha mentioned in the classics, patients are selected irrespective of sex, socio-economic status, and community, written consent from both patient and their relatives will be taken prior to the study. Computerised generated sampling technique will be used. Total 60 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group).Brahmi Churna Group A (trial group)  with dose 3gm bd with anupana goghrit and Tablet Donepezil Group B(Control group) with dose 5mg will be given to patients. Both drugs will be administered in churna form & tablet respectively for 45 days. Observations will be done on day 0, day 15, day 30 and day 45. Result of study will be drawn on basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients having cardinal features of Senile Dementia.
  • Patients having age between 60 to 80 years.
  • Patients having.
  • MMSC scoring 18-23 (Mild cognitive impairment).

排除标准

  • Patients with known case of delirium, confusion or other disturbances of consciousness, Parkinson’s disease, stroke, intracranial hemorrhage, brain tumors, recent history of alcoholism or drug dependence, use of any psychotropic drug, diabetes mellitus, etc.
  • Patients with physical impairment, such as walking, sitting, and holding one’s head up and eventually, results in difficulty in swallow, unable to control the micturition and feces.
  • Patients with loss of ability to communicate.

结局指标

主要结局

Improvement in score of minimental state examination and sign and symptoms of smruthibhransha

时间窗: 45 days

次要结局

  • Where the trial group stands in comparison with control group(18 months)

研究者

发起方
Dr Snehal Wasekar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Snehal Deorao Wasekar

SMBT Ayurved College and Hospital

研究点 (1)

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