Clinical Validation of Unani Pharmacopoeial Formulation Kushta-i-Sadaf in Sayalan al-Rahim due to Sue Mizaj Sada (Non-specific leucorrhoea)
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 Habb -e- Leemun in the treatment of Niqris (Chronic Gout) will be carried out on the basis of Pain (VAS-Visual Analogue Scale) and Gout Assessment Questionnaire.
研究概览
简要总结
This study is designed as a Single-centric open trial in patients with Sayalan al- Rahim (Non-specific leucorrhoea). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. Efficacy and safety parameters will be assessed clinically and recorded every week. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Detail of pharmacopeial formulation (NUFM-Part I, P. No 75)
| S. No. |
Ingredients
Quantity
|1.
Sadaf Kalan
250 gm
|2.
Sheer Madar
Q.S.
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
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •All women complaining of excessive white discharge with or without any of the following associated symptoms:
- •Waja‘ al-Zahr (Backache)
- •Naqahat (General Weakness)
- •Burning Micturition
- •Pruritus vulvae.
排除标准
- •Age below 15 & above 49 years
- •Patient with severe anemia (Hb % Equal or less than 8gm)
- •Known cases of uterine fibroid, prolapse, malignancy and ovarian tumour or cyst
- •Patients on oral contraceptive pills (OCPs)/Intrauterine devices (IUDs)/ Hormonal Replacement Therapy (HRT)
- •Known cases of sexually transmitted diseases
- •Patients on long-term medications for systemic illnesses
- •Any abnormal condition on p/s Examination
- •Patients having acute / acute on chronic/ Chronic PID as per CDC Criteria.
- •Pregnant and Lactating women.
结局指标
主要结局
The efficacy of the Habb -e- Leemun in the treatment of Niqris (Chronic Gout) will be carried out on the basis of Pain (VAS-Visual Analogue Scale) and Gout Assessment Questionnaire.
时间窗: At baseline and at the end of treatment. i.e, 0 & 4th week
次要结局
- Haematological and biochemical investigations for safety assessment i.e., Hemogram,LFT, KFT, Urine Examination: Routine & Microscopic.(At baseline and at the end of treatment. i.e, 0 & 4th week)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)