Clinical validation of Unani Pharmacopoeial formulation Mufarrah Shaikh ur Rais in Khafqaan (Palpitation)
试验速览
- 阶段
- 3 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 therapeutic efficacy will be assessed on the basis of reduction in Symptoms of Khafqaan (Palpitation).
研究概览
简要总结
This study is designed as a single centric open trial in patients with **Khafqaan (Palpitation)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week for four weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of “Mufarrah Sheikh ur Raisâ€
| S No |
Ingredients
Scientific Name
Quantity
|1.
Agar
Aquilaria agallocha Roxb.
20g.
|2.
Ilaichi Khurd
Elettaria Cardamomum
30g.
|3.
Berg Gaozaban
Borago Officinalis
50g.
|4.
Burada Sandal Surkh
Pterocarpus santalinus (Ht. Wd.)
15g.
|5.
Burada Sandal Safaid
Santalum album L.
30g.
|6.
Banslochan
Bambusa arundinaceae Retz
30g.
|7.
Behman Surkh
Salvia heamatodes L.
20g.
|8.
Tukhm Khurfa Siyah
Portulaca Oleraceae Linn
45g.
|9.
Tukhm Kahu
Lactuca sativa Linn.
45g.
|10.
Qust Shireen
Saussurea lappa, CB Clarke
20g.
|11.
Zaranbad
Curcuma Zedoaria
20g.
|12.
Sartan Sokhta
Scilla serrata ash
15g.
|13.
Gul e Surkh
Rosa damascene Herrm.
75g.
|14.
Maghz Tukhm Kharbuza
Cucumis melo L.
45g.
|15.
Maghz Tukhm Khayarain
Cucumis sativus L
45g.
|16.
Maghz Kadu Shirin
Cucurbita maxima Duch ex.Lam
45g.
|17.
Kafoor
Cinnamomum camphora
15g.
|18.
Busud Sokhta Mehlool
Corallium rubrum ash
15g.
|19.
Marwareed Mehlool
Mytilus margaritiferus
15g.
|20.
Abresham Muqarraz
Bombyx mori Cocoon
15g.
|21.
Qiwam Shakar
Saccharum officinarum
1.2kg
|22.
Rub Anar Shireen
Punica granatum
300g.
|23.
Rub Behi
Cydonia oblonga Mill
300g
|24.
Rub Seb
Malus sylvestris (L.) Mill
300g
|25.
Natroon Banjawi
3g.
|26.
Zafran
Crocus sativa L
3.5g.
|27.
Arq Gaozaban
Borago Officinalis
40ml
|28.
Warq Nuqra
5g.
|
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
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group of 19-
- •Patients having Palpitations with/without Ordinary physical activity with and without any of the following symptoms/ signs: Ghabrahat Sweating Nausea Vomiting Missed Heart Beat Sensation Fullness in chest Shortness of Breath.
排除标准
- •History of any heart diseases
- •History of hepatic, renal disorders, diabetes mellitus, hypertension, anemia, COPD
- •History of thyroid dysfunction
- •History of hypersensitivity to any ingredient of the study drug.
- •Participants with history of long term use of any other drugs such as anti-epileptic, anti-arrhythmic and anti-psychotic drugs etc.
- •History of Addiction (smoking, alcohol, drugs)
- •Pregnant and lactating women.
结局指标
主要结局
The therapeutic efficacy will be assessed on the basis of reduction in Symptoms of Khafqaan (Palpitation).
时间窗: At baseline, 1st,2nd,3rd and 4th week
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline and after 4 weeks)