Clinical validation of Unani pharmacopoeial formulation Majoon-e-Lana in Ḍu‘f A‘ṣÄb(Neurasthenia)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of trial drug will be assessed on the basis of Clinical Global Impression (CGI) improvement of severity scale and the Visual Analogues Scales for the sense of fatigue and well-being.
研究概览
简要总结
This study is designed as a single centric open trial in patients with Ḍu‘f A‘ṣÄb(Neurasthenia).After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. 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, 2nd week and on completion of the protocol therapy
Composition of Majoon-e-Lana
| S. No. |
Ingredients
Botanical / Scientific Name
Part Used
Quantity
|1.
Azaraqi Mudabbar
Strychnos nux-vomica L.
Seed
20g
|2.
Filfil Safaid
Piper nigrum L.
Fruit
10g
|3.
Filfil Siyah
Piper nigrum L.
Fruit
10g
|4.
Darchini
Cinnamomum zeylanicum B.
Inner stem bark
10g
|5.
Filfil Daraz
Piper longum L.
Fruit
10g
|6.
Jauzbuwa
Myristica fragrans H.
Endosperm
10g
|7.
Bisbasa
Myristica fragrans H.
Arillus
10g
|8.
Mastagi
Pistacia lentisus L.
Resin
10g
|9.
Sad Kufi
Cyperus rotundus L.
Rhizome
10g
|10.
Zanjabeel
Zingiber officinale R.
Rhizome
10g
|11.
Qaranful
Syzygium aromaticum M.
Flower bud
10g
|12.
Aamla
Emblica officinalis G.
Fruit
10g
|13.
Sumbul-ut-Teeb
Nardostachys jatamansi D.
Rhizome
10g
|14.
Heel Khurd
Elettaria cardamomum M.
Fruit
10g
|15.
Nankhwah
Trachyspermum ammiL.
Fruit
10g
|16.
Badiyan
Foeniculum vulgare M.
Fruit
10g
|17.
Zafran
Crocus sativus L.
Stamen & Stigma
10g
|18.
Sandal Safaid
Santalum album L.
Heart wood
10g
|19.
Ood-e-Balsan
Balsamodendronopobalsamum K.
Wood
10g
|20.
Agar
Aquilariaagallocha
Heart wood
10g
|21.
Asal /Qand Safaid
Honey/Sugar
600g
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender in the age group of 18-60 years
- •Patients having Ḍu‘f A‘ṣÄb(Neurasthenia) as per the diagnostic criteria.
排除标准
- •Patients below the age of 18 and above the age of 60 years
- •Patients having any systemic disease, chronic debilitating disease, T.B., Diabetes Mellitus etc.
- •History of any kind of addiction (Alcohol, Drugs and etc.)
- •Known case of Carpal tunnel syndrome, herniated disc syndrome, peripheral nerve injury.
- •Known cases of Any Neuromuscular abnormalities,neuromuscular junction disorders, Myasthenia gravis, Muscular disorders, Diabetic neuropathy, Autonomic neuropathies
- •Pregnancy and lactation.
结局指标
主要结局
Efficacy of trial drug will be assessed on the basis of Clinical Global Impression (CGI) improvement of severity scale and the Visual Analogues Scales for the sense of fatigue and well-being.
时间窗: At every 2 weeks for 6 weeks
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline, 2nd week & at 6th week.)