Clinical Validation of Unani Pharmacopoeial formulation Majoon Supari paak in SayalÄn al-Rahim (Leucorrhoea)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- improvement in the sign and symptoms of SayalÄn al-Rahim (Leucorrhoea)
研究概览
简要总结
his study is designed as a multicentric open trial in patients with SayalÄn al-Rahim (Leucorrhoea) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. 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.
Composition of Majoon Supari paak
1. KhurmaKhushk 500g
2. Fofil 250g
3. Majeeth 125g
4. Sheere Gao 10litres
5. Maghze Badam Shireen 500g
6. NishastaGandum Biryan 250g
7. Samaghe Arabi Biryan 250g
8. Arade Moong 125g
9. Raughane Zard 1kg
10. Qande Safaid 3kg
11. Khare Khask Khurd 500g
12. Samaghe Dhak 250g
13. Maghze Narjeel Khushk 250g
14. SalabMisri 55g
15. Darchini 55g
16. Qaranfal 55g
17. Heelkhurd 55g
18. Zanjabeel 55g
19. Jauzbuwa 25g
20. Gule Supari 15g
21. Gule pista 15g
22. Poste Kachnaal 10g
23. Poste Mughilaan 10g
24. Poste Sankhaholi 10g
25. Zafraan 50g
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 13.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢Female patients in the age group of 13-45 years.
- •â€¢Patients having excessive white discharge with or without any of the following associated symptoms •Waja‘ al-Zahr (Backache) •Naqahat (General Weakness) •Faqr al-Dam (Anaemia) (8-10 mg % in females).
排除标准
- •â€¢Patients having acute/ acute on chronic/Chronic PIDs (as per the CDC Diagnostic Criteria attached as an annexure-IV) •Patients on long-term medications.
- •â€¢Patients on Oral Contraceptives/IUDs. •Patients taking hormonal therapy.
- •â€¢Any abnormal condition on p/s Examination.
- •â€¢Pregnant and lactating women.
结局指标
主要结局
improvement in the sign and symptoms of SayalÄn al-Rahim (Leucorrhoea)
时间窗: 4 weeks
次要结局
- Hematological and biochemical assessments for safety(4 weeks)