Evaluation of Comparative Efficacy of Karanjadi Ghruta Pichu, Yasthimadhu Ghruta Pichu and Jatyadi Ghruta Pichu in the Management of Parikartika
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding after 3 weeks of treatment
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per comport generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into three groups.
The trial is a parallel-group, randomized, single-blind, standard - controlled trial. It will include, a 21 days treatment period, and a 7th, 14th & 21th day week follow-up period.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Parikartika (Acute Fissure in Ano) patients who clinically diagnosed / confirmed by inspection.
- •2.Patients’ age- between 18 and 60 years in either sex.
- •3.Fissure-in-Ano patients of with controlled systemic diseases like Diabetes; and Hypertension 4.Willing full to participate and able to complete the study period.
排除标准
- •1.Parikartika (Fissure in Ano) present with secondary condition as Ulcerative colitis, Chron’s disease, Syphilis and Tuberculosis.
- •Patients with systemic disease like Diabete and Hypertension which is uncontrolled.
- •3.Patients with HIV and HbsAg positive.
- •4.Any condition which may jeopardize the study.
结局指标
主要结局
To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding after 3 weeks of treatment
时间窗: To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding after 3 weeks of treatment
次要结局
- To assess efficacy of Karanjadi Ghruta Pichu in the Management of Parikartika in total effect of healing, pain, spasm & bleeding(before treatment)