Randomized open labelled controlled clinical study of efficacy of raktavisravanottar kanadya churna pratisarana in dantaveshtaka with special reference to periodontitis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- efficacy of trial drug on periodontitis on assesment criteria-Complete Improvement
研究概览
简要总结
Null Hypothesis
There is no role of Raktavisravanottar Kanadya Churna Pratisarana twice in a day morning and evening for 21 Days in the management of Dantaveshtaka.
Alternative Hypothesis H1
Raktavisravanottar Kanadya Churna Pratisarana twice in a day morning and evening for 21 days is significantly effective in the management of Dantaveshtaka.
Alternative Hypothesis H2
Raktavisravanottar Kanadya Churna Pratisarana twice in a day(morning and evening) for 21 days is significantly better than Jeerakadya churna twice in a day morning and evening for 21 days in the management of Dantaveshtaka.
Selected 200 patients will be randomly distributed into two equal groups each comprising 100 patient.
Group will be named as Group A and Group B.
Group A will be Trial Group
Group B will be Control Group
- Trial Group
Randomly selected 100 patients will be treated with Sthanik Raktavisravana on 1st day followed by Kanadya Churna Pratisarana twice in a day for 21 days.
- Control Group
Randomly selected 100 patients will be treated with Sthanik Raktavisravana on 1st day followed by Jeerakadya Churna Pratisarana twice in a day for 21 days.
Each patient included in the study will be given treatment for 21 days.
Follow up on 7th 14th 22nd day of the study
Study will be carried out in 3 years duration of PhD. On each step data will be recorded observation from statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Diagnosed case of Dantaveshtaka. Shotha (Inflammation of margins and or Gums) Puyasrava (Pus discharge from the Gums) Raktasrava (Bleeding from the Gums) Chaladanta (Moveable tooth)
- •60 Years of age. Patient of either Gender. Irrespective of socioeconomic Status.
排除标准
- •Acute/severe Systemic/oral diseases Sensitive to local anaesthetic agents.
- •Tooth malocclusion/ Badly carries tooth.
- •Use of analgesics/ antibiotics in last one week.
- •Bleeding disorders, severe anaemia Patients on drugs which may cause gingival hypertrophy.
- •Patient is not willing for treatment.
结局指标
主要结局
efficacy of trial drug on periodontitis on assesment criteria-Complete Improvement
时间窗: 22nd day
Moderate Improvement Mild Improvement
时间窗: 22nd day
Unchanged
时间窗: 22nd day
次要结局
- to compare the efficacy of raktavisravanottar kanadya churna pratisaran with raktavisravanottar jeerakadya churna pratisaran(22nd day)
研究者
Dr Shital Rajkumar Meshram
Government Ayurved college and hospital vazirabad nanded