Clinical Validation of Unani pharmacopoeial formulation Habb-e-Anjeer in Bawaseer (Haemorrhoids).
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 efficacy of the study drug in the treatment of Bawaseer (Haemorrhoids) will be assessed on the basis of Haemorrhoidal Disease Symptom Score i.e., Pain, Itching, Bleeding, soiling, and prolapse as proposed by Nyström et al (2010).
研究概览
简要总结
This study is designed as an open-label, single-centre prospective clinical validation study in participants with Bawaseer (Haemorrhoids)****. After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks (i.e.,0, 2nd, 4th and 6th 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, first follow-up and on completion of the protocol therapy (i.e., 0, 2nd, and 6th weeks).
Composition of Habb-e-Anjeer (NFUM, Part- II, P.N. 8)
| S. |
No.
Ingredients
Botanical Name
Quantity
|1
Badiyan
Foeniculum vulgare Mill
40 g
|2
Post-e-Halela**Zard
Terminalia chebula Retz.
40 g
|3
Post-e-Balela
Terminalia bellirica (Gaertn.) Roxb.
40 g
|4
Amla
Emblica officinalis Gaertn.
40 g
|5
Muqil
Commiphora wightii (Arn.)
40 g
|6
Rasot
Berberis aristata DC.
40 g
|7
Tukhm-e-Gandana
Asphodelus tenuifolius Cav.
10 g
|8
Anjeer
Ficus carica L.
5 in number
|9
Maweez
Vitis vinefera L.
70 g
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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 Internal Haemorrhoids presenting with any of the following symptoms:
- •Mucoid Anal and Perianal Discharge
- •Pruritus Ani (Hikka al-Maq‘ad)
- •Rectal and Anal Pain (Waja-al-Maq‘ad)
- •Rectal Bleeding.
排除标准
- •Third & Fourth Degree Internal Haemorrhoids,
- •Severe Anaemia (Hb less than 8 g/dL)
- •Known cases of fistula and fissure in anal canal
- •Patient with rectal prolapse, polyp and abdominal mass.
- •Known cases of IBD & Bowel carcinoma.
- •Immuno-compromised clinical conditions such as diabetes mellitus type 2, HIV/AIDS, cancer, etc.
- •Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.)
- •Pregnancy and lactation.
结局指标
主要结局
The efficacy of the study drug in the treatment of Bawaseer (Haemorrhoids) will be assessed on the basis of Haemorrhoidal Disease Symptom Score i.e., Pain, Itching, Bleeding, soiling, and prolapse as proposed by Nyström et al (2010).
时间窗: At baseline and every two weeks. (i.e., 0, 2nd, 4th, and 6th week)
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline, first follow up and the end of treatment. (i.e., o, 2nd and 6th week))
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)