Clinical Validation of Unani Pharmacopoeial Formulation Habb e Jadwar Kochak in Ḍu‘f al-DimÄgh (Cerebro-asthenia)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Improvement in sign and symptoms of Ḍu‘f al-DimÄgh (Cerebro-asthenia)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with **Ḍu‘f al-DimÄgh (Cerebro-asthenia)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 6 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition ofHabb e Jadwar Kochak
| S. No. |
Ingredients
Botanical Name
Quantity
|1.
Jadwar
Delphinium denudatum Wall.
10 g
|2.
Banafsha
Viola odorata
10 g
|3.
Zafran
Crocus sativus
10 g
|4.
Ambar Ash-hab
Ambra grasea
5 g
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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 Ḍu‘f al-DimÄgh (Cerebro-asthenia) having subjective complaints of cognitive impairment: a.
- •Memory loss b.
- •Mild headache c.
- •ButlÄn-i-Takallum (Speech impairment) e.
- •ButlÄn-i-TahrÄ«r (Writing impairment)
- •MMSE score of 10-23 representing mild to moderate cognitive impairment.
排除标准
- •The patients having any of the following criteria will be excluded from the study:
- •Clinical presentation and/or history of any significant organic neurological diseases including space occupying lesions, stroke, head injury, seizure, and mental retardation.
- •Secondary causes of dementia including hypothyroidism or hyperthyroidism.
- •Known cases of B12 vitamin deficiencies.
- •Clinical presentation and known case of a chronic disease that requires long-term treatment.
- •Patients on Psychotropic Drugs
- •H/o alcohol or substance abuse or dependence.
- •H/o Hypersensitivity to the study drug or any of its ingredients
- •Pregnant and lactating women.
结局指标
主要结局
Improvement in sign and symptoms of Ḍu‘f al-DimÄgh (Cerebro-asthenia)
时间窗: 6 Weeks
次要结局
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and after every two weeks)