A Single blind, Randomized, Parallel group study to compare efficacy and safety of Unani Medicine Kit formulation– Qurs Mulaiyin with Dulcolax in patients with Daimi Qabz(Chronic Constipation)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in sign and symptoms of Daimi Qabz (Chronic constipation)
研究概览
简要总结
This study is designed as a single blind randomized parallel group trial in patients with Daimi Qabz(Chronic Constipation). Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients enrolled in the study will receive the medicine Qurs Mulaiyin or Tab Dulcolax as allocated by randomization method. The total duration of treatment will be one week and the follow-up for all clinical parameters will be conducted at 3rd& 7th day. The laboratory tests will be conducted at baseline and end of the treatment.
Composition of Qurs Mulaiyin
| S. No. |
Ingredients
Botanical / English Name
Quantity
|
Zanjabeel
ZingiberofficinaleRosc.
6 gm
|
Sana
Cassia augustifoliaVahl
6 gm
|
Gul-e-Surkh
Rosa damascenaMill
3 gm
|
Bekh-e-Jalapa
Ipomoea purgaHayne
6 gm
|
Namak Lahori
1.5 gm
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 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
- •Participants of either sex in the age group 18 to 65 years.
- •Patients meeting the “Rome III diagnostic criteria for functional constipation which were fulfilled for the past 3 months with symptoms onset at least 6 months before diagnosis: Must include two or more of the following: a.
- •Straining during at least 25% of defecations b.
- •Lumpy or hard stool in at least 25% of defecations c.
- •Sensation of incomplete evacuation for at least 25% of defecations d.
- •Sensation of anorectal obstruction/blockage for at least 25% of defecations e.
- •Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor) f.
- •Fewer than three defecations per week
- •Loose stool being rarely present without the use of laxatives
- •Insufficient criteria for irritable bowel syndrome.
排除标准
- •Patients on chronic laxative medication (>60 days) and/or who were on medications known to cause constipation (like opioid analgesics, antidepressants, anticonvulsants) were excluded.
- •Known case of a megacolon/megarectum.
- •Known cases of HIV/AIDS, cancer, etc.
- •Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •Known hypersensitivity to study drug or any of its ingredients
- •Pregnant and Lactating females
- •Any systemic disorder requiring prolonged treatment.
结局指标
主要结局
Improvement in sign and symptoms of Daimi Qabz (Chronic constipation)
时间窗: 1 week
次要结局
- Hematological and biochemical assessment for safety assessment(1 week)