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临床试验/CTRI/2026/02/102735
CTRI/2026/02/102735尚未招募3 期

Post Stroke Depression - A Parallel arm randomized placebo controlled clinical trial analyzing the biocompatibility and therapeutic potential of unani formulation Habb-e-aftimoon

Government nizama tibbi college and hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1

研究概览

简要总结

Post-stroke depression (PSD) is a prevalent neuropsychiatric complication, affecting up to one-third of stroke survivors, and is associated with impaired functional recovery, social isolation, diminished quality of life, suicidal tendencies, and considerable caregiver burden. Globally, stroke and depression are among the leading contributors to disability-adjusted life years. PSD has a reported prevalence of 25–79%, influenced by diagnostic criteria and patient selection. In Unani system of medicine, depression is not mentioned as an individual disease entity rather it is mentioned as a symptom or group of symptoms of Melancholy (Melancholia) in which the mental functions of the individual are deranged leading to constant grief, fear and dubious aggression, attributed to deranged black bile (ghair tabayi sauda) humor imbalance.Conventional pharmacotherapy, including SSRIs and TCAs, shows delayed onset, modest efficacy, and potential risk of stroke recurrence. Pathophysiology of PSD is multifactorial, involving decreased levels of monoamines, Increased neuro inflammation with dysregulation of hypothalamic - pituitary - adrenal axis, decreased neurotrophic support such as BDNF and glutamate mediated excitotoxicity. Habb e Aftimoon 5-10 g is considered to be therapeutically useful in malankhuliya and waswaas its actions are Munaqqi e dimagh (drugs clearing vitiated humour from brain) and Mulaiyin (laxative).

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients exhibiting mild-moderate depression as assessed by ICD 10 criteria of depression 2.Patients having single ischemic or hemorrhagic stroke documented by CT scan or MRI before enrollment 3.Patients having a history of stroke more than 3 months 4.Willing to sign the informed consent form.

排除标准

  • 1.Patients with Previous history of more than one episode of stroke.
  • 2.Previous history of known psychiatric disorders.
  • 3.Severe Aphasia.
  • 4.Chronic Alcoholism 5.Uncontrolled hypertension and Diabetes mellitus 6.Pregnant and lactating mothers 7.Medical conditions like Epilepsy, Renal and Hepatic diseases.

研究者

发起方
Government nizama tibbi college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Khizra Fatima

GOVERNMENT NIZAMIA TIBBI COLLEGE AND HOSPITAL

研究点 (1)

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