A Pharmaco-clinical study to evaluate the effectiveness of Arjuna[Terminalia arjuna Roxb],Manjistha[Rubia cardifolia Linn] and Vasa[Adhatoda vasica Nees] patra churna lepa with Madhu in the management of Vyanga w.s.r. to melasma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Essential criteria
研究概览
简要总结
Women of middle age often suffers with dark patches on face generally on cheeks forehead and nose, which often decreases their confidence and make them stressful for their appearance ,therefore i have selected this trial.This research evaluate the efficacy of arjun,manjistha and vasa powder .This research is parallel group randomised clinical study of 60 patients.
Group A [[n =30] - Arjun ,manjistha and vasa powder lepa with honey will be given for external application twice a day for a period of two months
Group B [n = 30] - This group is proposed to be given lepa twice along with it the powder will be also given for internal use twice daily with lukewarm water after meal for a period of two month.
Duration of trial - 2 months
Follow up = the follow up conducted during study period for once in 15 days,after completion of trial of two months,the follow up without drug after 15 days for one month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Both acute and chronic cases of vyanga with special reference to mealasma will be treated .patient willing to participate in above mentioned trial .Diagnosed with classical features of vyanga as described in samhitas.
排除标准
- •Age group less than 30 years and more than 50 years Hyper pigmentation caused due to any known cases of systemic diseases like Addison disease,Cushing syndrome.
- •People suffering from chronic liver and renal disorders.
- •Hyper pigmentation caused by tumors like malignant melanoma Pregnant women patients who are on chemotherapy or radiotherapy will be excluded.
结局指标
主要结局
Essential criteria
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
1 Shyavavarna[grey brown]
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
2 Niruja[painless]
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
3 Tanu[non elevated]
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
4 Mandal[patches with irregular border]
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
Non Essential criteria
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
1 Familial history
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
2 Sun exposure
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
Objective criteria
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
1 Area of lesion
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
2 Visibility of pigmentation
时间窗: Tthe follow up conducted during study period for once in 15 days.After completion of trial of two months ,the follow up without drug after 15th day
次要结局
- CBC(LFT,KFT)
研究者
Sweta Gupta
State Ayurvedic College and Hospital Lucknow