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临床试验/CTRI/2024/07/071310
CTRI/2024/07/071310尚未招募2/3 期

A Comparative Study On The Effect Of Oral Administration Of Lajjalu Churna With And Without Kalpit Pichha Basti In The Management Of Grahani Dosh W.S.R IBD

Dayanand Ayurvedic College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Following index will be assessed for the reduction in their score

研究概览

简要总结

The total of 60 patients will be selected who are between age group of 20 to 60 years of either sex who are diagnosed with Grahani Rog on the basis of sign and symptoms. Patients will be divided into two groups (Trial Group A and Trial Group B). Group A will be given oral administration of Lajjalu Churna and Kalpit Piccha Basti and Group B will be given  oral administration of  Lajjalu Churnaand conduct a clinical study to evaluate the effect of oral administration of Lajjalu Churna in the management of Grahani Rogw.s.r. IBD; to evaluate the effect of oral administration Lajjalu Churna with Kalpit Piccha Basti in the management of Grahani Rog w.s.r. IBD and to compare the effect of oral administration of Lajjalu Churna with and without Kalpit Piccha Basti in the management of Grahani Rog w.s.r. IBD. The total duration of study will be 18 months.

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

入选标准

  • Patients who are willing to participate in the trial.
  • Patients fulfilling the diagnostic criteria.
  • Patients of either sex who are between the age group 20 to 60 years.
  • Patients who are diagnosed with Grahani on the basis of with atleast 4 signs and symptoms Out of eleven mentioned in the texts
  • Patients who are fit for Basti Chikitsa.

排除标准

  • Patients with the age less than 20 and more than
  • Patients who are suffering from long standing systemic diseases e.g.- hypertension, diabetes, malignancy.
  • Patients with long term Steroid and cytotoxic treatment.
  • Pregnant or lactating women.
  • Patients who are unfit for Basti Chikitsa.
  • 7.Tubercular IBD will be excluded.

结局指标

主要结局

Following index will be assessed for the reduction in their score

时间窗: Assessment | will be done in both the groups. | Day 0 (At the time of enrollment of the patient) | Day 15 (After 7 days of Basti treatment) | Day 30 (After 30 days of oral administration of Lajjalu Churna ) | Day 45 (After 45 days of oral administration of Lajjalu Churna ) | Day 60 (At follow up)

For Chron’s Disease- Harvey Bradshaw Index

时间窗: Assessment | will be done in both the groups. | Day 0 (At the time of enrollment of the patient) | Day 15 (After 7 days of Basti treatment) | Day 30 (After 30 days of oral administration of Lajjalu Churna ) | Day 45 (After 45 days of oral administration of Lajjalu Churna ) | Day 60 (At follow up)

For Ulcerative Colits Scoring system for the Powell-Tuck Index

时间窗: Assessment | will be done in both the groups. | Day 0 (At the time of enrollment of the patient) | Day 15 (After 7 days of Basti treatment) | Day 30 (After 30 days of oral administration of Lajjalu Churna ) | Day 45 (After 45 days of oral administration of Lajjalu Churna ) | Day 60 (At follow up)

次要结局

  • Following index will be assessed for the reduction in their score(1.For Chron’s Disease- Harvey Bradshaw Index)

研究者

发起方
Dayanand Ayurvedic College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Archana Sharma

Dayanand Ayurvedic College

研究点 (1)

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