Comparative Clinical Validation study of Unani Pharmacopoeial Formulation Jawarish-e-Tamar Hindi vs Jawarish-e-Shahi in Khafaqan (Palpitation)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 318
- 试验地点
- 3
研究概览
简要总结
This study is designed as a multi-centric, Randomized, Parallel Group, Active Controlled trial in patients with Khafaqaan (Palpitation). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline and subsequently at weekly intervals (Week 1, Week 2, Week 3, and Week 4) during the protocol therapy. The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 04 weeks. Laboratory parameters for safety assessment will be conducted at baseline, first follow-up and on completion of the protocol therapy (i.e., 0, 1st & 4th weeks).
Composition of Jawarish-e-Tamar Hindi
| S. No |
Ingredients
Scientific name
Quantity
|1.
Gul-e-surkh
(Rosa damascene Mill)
20g
|2.
Kishneez
(Coriander sativum Linn)
20g
|3.
Mastagi
(Pistacia lentiscus Linn)
10g
|4.
Dana heel khurd
(Elettaria cardamum)
10g
|5.
Zarishk
(Berberis aristate)
10g
|6.
Tabasheer
(Bambusa arundinaceae)
10g
|7.
Sazij hindi
(Cinnamomum tamala)
10g
|8.
Post turanj
(Citrus medica)
10g
|9.
Sandal safaid
(Santalum album)
10g
|10.
Aab anar
(Punica granatum)
100ml
|11.
Aab tamar hindi
(Tamarindus indica)
150ml
|12.
Muraba amla
(Embelica officinalis)
150g
|13.
Qand safaid
(Saccharum officinarum)
600g
National Formulary of Unani medicine Part I, p.no 105
Composition of comparator: Jawarish Shahi
| S. No |
Ingredients
Scientific name
Quantity
|1.
Murabba*-e-*Halela
(Terminalia chebula Roxb.)
5 No.
|2.
Murabba*-e-*Aamla
(Emblica officinalis Gaertn.)
4 No.
|3.
Araq-e-Bed Mushk
(Salix caprea L.)
Q.S.
|4.
Kishneez
(Coriander sativum Linn)
12 g
|5.
Heel khurd
(Elettaria cardamom Maton)
3 g
|6.
Qand safaid
(Saccharum officinarum)
2 times of all ingredients
National Formulary of Unani medicine Part I (revised) p.no 144-145
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group of 18-65 years.
- •Patients experiencing palpitations who exhibit any of the following symptoms: I.
- •Chest discomfort.
- •Shortness of breath III.
- •Missed Heart Beat Sensation.
- •Awareness of heart beating.
排除标准
- •Patients below 18 years and above 65 years of age.
- •Patients with cardiac pacemakers or other implanted electronic devices.
- •Any gross abnormality detected on ECG.
- •Patient with History of severe hepatic, renal/ respiratory disorder, diabetes mellitus, hypertension, hyperthyroidism, anemia.
- •Pregnant and lactating women.
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)