AN OPEN RANDOMISED DOUBLE ARM CLINICAL TRIAL TO EVALUATE AND COMPARE THE EFFICACY OF SIDDHA HERBAL FORMULATIONS “VENPOOSANI NEI†(INTERNAL) VERSUS “VENPOOSANI NEI (internal) WITH THIRIPHALA CHOORNAM WASH (external) IN “VELLAI NOI†FOR FEMALE PATIENTS ATTENDING SCRI - CHENNAI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Trial is to show vaginal swab negative for micro-organism
研究概览
简要总结
This is an interventional trial to evaluate and compare the efficacy of two Siddha formulations. Vellai noi is compared with leucorrhoea in modern medicine. Abnormal genital discharge (Leucorrhoea) is quit a frequent complaint of women in day today life. If leucorrhoea is untreated it leads to complications of chronic abdominal pain, recurrent infections, pelvic inflammatory diseases. Primary objective of the trial is to evaluate and compare the efficacy of Siddha herbal drug "Venpoosani Nei" (Internal ) and Venpoosani (Internal) with Thiripala choornam wash(External) in female Vellai noi. Primary objective will be determined by vaginal smear test. Secondary objective of the trial is to compare the improvement in signs and symptoms of trial participants using severity score and to determined whether administration of venpoosani nei alters the lipid levels. Venpoosani nei contains drugs having anti microbial, anti oxidant, anti inflammatory and anti diuretic which is essential to cure leucorrhoea-Vellai noi. In Siddha meteria medica, Kadukkai(Treminalia chebulla) , Nellikkai (Emblica officinalis), Thandrikkai (Terminalia bellerica) are indicated for Vellai noi.
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
- 18.00 Year(s) 至 50.00 Year(s)(—)
入选标准
- •1 Age – 18 to 50 Years 2 Gender – Married Female 3 Thick whitish or yellowish or greenish discharge from vagina with foul smell 4 Itching and burning sensation in vulva 5 Vaginal swab test positive for micro-organism 6 Dysuria 7 Lower abdominal pain 8 Pain in lumbar region.
排除标准
- •1.White discharge with bleeding 2.Ovarian cyst or tumor, prolapse 3.Pregnancy and lactation 4.Diabetes 5.Physiological vaginal discharge 6.Use of antibiotics or local vaginal formulation within the previous month.
结局指标
主要结局
Trial is to show vaginal swab negative for micro-organism
时间窗: After 40 days
次要结局
- 1.Reduction of signs and symptoms of vellai noi (leucorrhea) – (Severity score)(2.To assess whether administration of venpoosani nei alter the lipid levels by measuring lipid profile, before and after treatment.)
