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临床试验/CTRI/2024/03/064421
CTRI/2024/03/064421已完成2/3 期

Efficacy of Priyangavadi Churna Pratisarana,Triphala Churna orally ,with or without Raktamokshana(Prachchana Vidhi) in the management of Shitada (Gingivitis) - an open labelled randomized comparative clinical trial

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Efficacy of intervention on signs and symptoms of Shitada (Gingivitis).

研究概览

简要总结

The trial is randomized clinical trial to evaluate the efficacy of Priyangvadi Churna Pratisarana, Triphala Churna orally with and without Raktamokshana (Prachchhana Vidhi) in the management of Shitada (Gingivitis). Total 30 patients will be enrolled in the study. Selected patients will be divided into two groups on the basis of computer generated randomization. In the study Priyagvadi Churna Pratisaran 3gm. BD, Triphala Churna 5gm. HS orally will be given after meal with luke warm water for 1 month with Raktamokshana (Prachchhana Vidhi). In another group only Priyagvadi Churna Pratisaran 3gm. BD, Triphala Churna 5gm. HS orally will be given after meal with luke warm water for 1 month without Raktamokshana (Prachchhana Vidhi). Followup will be carried out at 15 days interval for 1 month on routine medicine.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient of either sex aged between 18 to 60 years of age presenting with signs and symptoms of Shitada(Gingivitis) described as per Ayurveda and Modern Science will be included in the study.
  • 2.The diagnosis of the disease shall be done with signs and symptoms of Shitada(Gingivitis)i.e.Akasmata Rakta Srava (Bleeding), Shotha(Inflammation), Krishnata(Discoloration of gums), Mukha Daurgandhya (Halitosis), Vedana (Pain), DantamamsaPrakledata(Moistness), Paka (Pus discharge) and DantamamsaMriduta (Sponginess).
  • 3.Patients having minimum two clinical symptoms of Shitada will be included in the study.Primary symptom is Akasmata Rakta Srava (Bleeding) along with any other symptom of Shitada.

排除标准

  • 1.Patients below18 years and more than 60 years of age.
  • 2.Patient with periodontal pocket with pus discharge.
  • 3.Patients with evidence of malignancy, HIV and Diabetes Mellitus.
  • 4.Any systemic disorder which may alter the result of the study i.e, Haemophilia or other bleeding disorders.
  • 5.Pregnant women shall be excluded.
  • 6.Patients who are using anticoagulant drugs like Aspirin etc.
  • will be excluded.
  • 7.The patients taking any other systemic drugs which can alter the result of the study.

结局指标

主要结局

Efficacy of intervention on signs and symptoms of Shitada (Gingivitis).

时间窗: during the treatment period at baseline | 4 Weeks

次要结局

  • Improvement in the quality of life of the patient Assessment of recurrence of signs & symptoms of Shitada (Gingivitis) during follow up period(During follow up period on 15th & 30th day)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ganesh Dan

ITRA Jamnagar

研究点 (1)

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