Clinical study to validate the safety and efficacy of joshanda ( Darchini, Saleekha, Saad, Bisbasa and Qaranfal) in the management of Warm-e-Ghudda-e-Mazi (Benign Prostatic Hyperplasia): An open label, randomized, standard control study .
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Central Council for Research in Unani Medicine New Delhi
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- USG (prostate specific)
概览
简要总结
Benign prostate hyperplasia (BPH) is the expansion of prostate gland in elderly men, which can cause partial or complete bladder outlet obstruction producing them to have lower urinary tract symptoms. It is a common urological disease among older men. The age specific prevalence of BPH has been estimated to be 8% in the fourth decade of life, 50% in the sixth decade of life and 80% in the ninth decade of life . Since BPH itself is not lethal, urine flow obstruction is its most significant outcome that has a negative impact on person’s ability to engage in physical activity and their mental health. Dribbling of urine, frequent micturation especially at night, a hesitant, interrupted or weak stream of urine, sense of incomplete bladder emptying are some symptoms of BPH. BPH has been described under the headings of Warm-e- Ghudda-e-Mazi,Salaa-e--Ghudda-e-Mazi ,and Warm-e- Unaq-e- Masaana in Unani system of medicine. However, symptomatic BPH treatment is typically found in our classical writings under several categories such as Ehtabas-e-baul , Taqteer-ul -baul and Usr-e-baul . The symptoms and the size of the prostate can be reduced with medical therapy, however allopathic medicine does have number of negative effects. Since ancient times, Unani physicians have used secure herbal treatments to treat the BPH symptoms. However, there are not enough credible scientific studies to backup this practice. Scientific confirmation of these safe medications is urgently required. The purpose of the current study is to find a safe and effective treatment for BPH by examining how polyherbal Unani formulation affects BPH patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 79.00 Year(s)(—)
- 性别
- Male
入选标准
- •A diagnosed case of BPH (Warm-e- Ghudda-e- Mazi) that meets the following criteria;
- •Males in the age range of 40 -79 years.
- •Patient expressing concerns about hesitation, frequency and urgency of urination.
- •Patients with a serum PSA level of 4 to 10 ng/ml.
排除标准
- •Patients under the age of 40 and older than 79 years.
- •Patients that are mentally disturbed.
- •Refusal to provide consents by patients.
- •Known case of Hypertension, CHD, CKD, liver disease and uncontrolled diabetes.
- •PSA levels over 10ng/ml, suspecting carcinoma
- •Complete urine retention.
结局指标
主要结局
USG (prostate specific)
时间窗: Serum PSA on day 0 and day 91 | USG (prostate specific) on day 0 and day 91
Serum PSA
时间窗: Serum PSA on day 0 and day 91 | USG (prostate specific) on day 0 and day 91
次要结局
- Improvement in IPSS (international prostate symptom score) Arbitary scale(Improvement in QOL ( Quality of life))