A Randomised Controlled Clinical Study To Evaluate The Effect Of Rasabhra Guggulu InThe Management Of Uttana Vatarakta W.S.R. To Varicose Veins.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- VCSS[VENOUS CLINICAL SEVERITY SCORE]is used to Monitor the Changes in Venous diseases before and after the treatment using Subjective Parameters like shoola,daha and Objective Parameters like Shyavraktatwak,Aakunchana.
研究概览
简要总结
This is a Randomized,open label,parallel group study comparing the safety and efficacy of Controlled drug [group-A] Kaishora Guggulu 3000 mg daily and the Trial drug [group-B] Rasabhra Guggulu 6000 mg daily for 28 days for 15 patients to each groups and will be conducted in Shri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Kuthpady,Udupi, Karnataka, India. The Primary outcome measures will be assessed through VCSS [ Venous Clinical Severity Score] Before and After the treatment using Subjective and Objective parameters. The Secondary outcome incorporate the range of signs and symptoms of chronic venous disease to characterize the severity from C0 to C6 through CEAP [ clinical,ethiologic,anatomic,pathophysiologic] classification scheme and Disease specific Quality of Life will be Measured by Aberdeen Varicose veins Questionnaire [ AVVQ]. Hence an effort has been planned through this clinical study to prove the efficacy of Rasabhra Guggulu as effective against Uttana vatarakta w.s.r. to Varicose Veins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •PATIENT PRESENTING WITH MORE THAN FOUR OUT OF EIGHT SIGNS AND SYMPTOMS OF UTTANA VATARAKTA/VARICOSE VEINS WILL BE INCLUDED IN THE STUDY.
- •KANDU-ITCHING DAHA-BURNING SENSATION RUK-PAIN AAYAM-FEELING OF STRETCHING TODA-PRICKING PAIN SPHURANA-PULSATING SENSATION AAKUNCHANA-CONTRACTION SHYAVRAKTATWAK-SKIN DISCOLORATION.
排除标准
- •PREGNANT WOMEN PROGRESSIVE GANGRENOUS CHANGES THROMBOPHLEBITIS BLEEDING ACUTE FAT NECROSIS ULCERATION DEEP VEIN THROMBOSIS.
结局指标
主要结局
VCSS[VENOUS CLINICAL SEVERITY SCORE]is used to Monitor the Changes in Venous diseases before and after the treatment using Subjective Parameters like shoola,daha and Objective Parameters like Shyavraktatwak,Aakunchana.
时间窗: Time Frame [At baseline, 4 week]
次要结局
- Disease-Specific Quality Of Life Measured by Aberdeen Varicose Veins Questionnaire [AVVQ](4 week)