Comparative Clinical Validation study of Unani Pharmacopoeial Formulation Majoon Brahmi vs Majoon e Nisyan in Zof-e-Dimag wa Hafiza (Cerebro-asthenia)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The safety and efficacy of Unani Pharmacopeial formulation Majoon Brahmi in comparison with Majoon e Nisyan in Zof-e-Dimag wa Hafiza (Cerebro-asthenia) will be carried out on the basis of Mini Mental State Examination (MMSE) score
研究概览
简要总结
This study is designed as a Single centric,Randomized, Parallel Group, Active Controlled trial in patients with Zof-e-Dimag wa Hafiza (Cerebro-asthenia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every 14days (i.e., Baseline, at days 14th, 28th, and 42th). The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 6 weeks (42 days). Laboratory parameters for safety assessment will be conducted at baseline, first follow-up and on completion of the protocol therapy (i.e., at 0, 14th and 42th day).
Composition of Majoon Brahmi
| S. No. |
Ingredients
Botanical Name
Quantity
|1.
Agar
Aquilaria agallocha Roxb.
20 gm
|2.
Badiyan
Feoniculum vulgare Mill.
40 gm
|3.
Brahmi Boti
Bacopa monnieri (Linn).
200 gm
|4.
Banslochan
Bambusa bambos (L).
40 gm
|5.
Ilaichi Khurd
Elettaria cardamomum (L).
20 gm
|6.
Darchini
Cinnamomum zeylanicum Blume,
10 gm
|7.
Kishneez khushk (Dhaniya)
Coriandrum sativum Linn*.*
40 gm
|8.
Mastagi Roomi
Pistacia lentiscus Linn*.*
20 gm
|9.
Maghz Badam Shireen
Prunus amygdalus Batsch*.*
100 gm
|10.
Maghz Pista
Pistacia vera Linn.
100 gm
|11.
Qiwam Shakar
Sugar syrup
1.8 kg
Composition of Majoon Nisyan
| S. No. |
Ingredients
Botanical
Quantity
|1.
Asärün(Tagar)
Valeriana wallichii DC
20 gm
|2.
Bädranjboyä
Melissa parviflora Benth
20 gm
|3.
Irsä
Iris ensata Thunb.
20 gm
|4.
Sumbul al-Tib
Nardostachys jatamansi DC
20 gm
|5.
Waj
Acorus calamus L.
20 gm
|6.
Behman Surkh
Salvia haematodes L.
40 gm
|7.
Post Halela Zard
Terminalia chebula Retz.
40 gm
|8.
Pipal Kalän
Piper longum L.
10 gm
|9.
Täj Qalmi
Cinnamomum cassia (L.) J. Presl
20 gm
|10.
Darchini
Cinnamomum zeylanicum Blume
20 gm
|11.
Darunaj Aqrabi
Doronicum hookeri C. B.Clarke ex Hook. f.
20 gm
|12.
Zanjbil
Zingiber officinale Roscoe
10 gm
|13.
Sa’ad Kufi
Cyperus scariosus R.Br.
20 gm
|14.
Ood Salib
Paeonia emodi Royle
20 gm
|15.
Filfil Siyah
Piper nigrum L.
10 gm
|16.
Kabab chini
Piper cubeba L. f.
20 gm
|17.
Kundur
Boswellia serrata Roxb.ex Colebr.
20 gm
|18.
Maghz-e-chironji
Buchanania lanzan Spreng.
30 gm
|19.
Maghz-e-Narjil
Cocos nucifera L.
40 gm
|20.
Abresham muqarraz
Bombyx mori(Silkworm)
20 gm
|21.
Mawiz Munaqqa
Vitis vinifera L.
250 gm
|22.
Za’fran
Crocus sativus L.
1.8 gm
|23.
Arq-i-Gaozban
Borago officinalis L.
20 ml
|24.
Mastagi rumi
Pistacia lentiscus L.
20 gm
|25.
Raughan zard
Pure Ghee
5 gm
|26.
Qiwam-e-Shakri
Sugar syrup
1.3 kg
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
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Zof-e-Dimag wa Hafiza (Cerebro-asthenia) having subjective complaints of cognitive impairment: .
- •Memory loss .
- •Mild headache .
- •speech impairment .
- •writing impairment
- •MMSE score of 10-23 representing mild to moderate cognitive impairment.
排除标准
- •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.
- •Known case of chronic diseases that requires long-term treatment.
- •Patients on Psychotropic Drugs
- •H/o alcohol or substance abuse or dependence.
- •Pregnant and lactating women.
结局指标
主要结局
The safety and efficacy of Unani Pharmacopeial formulation Majoon Brahmi in comparison with Majoon e Nisyan in Zof-e-Dimag wa Hafiza (Cerebro-asthenia) will be carried out on the basis of Mini Mental State Examination (MMSE) score
时间窗: At Baseline and after every 14 days, (i.e., 0, 14th,28th and 42th day)
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline, at first follow up and at the end of treatment. (i.e., At 0, 14th and 42th day))
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)