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临床试验/CTRI/2025/02/081355
CTRI/2025/02/081355尚未招募2 期

An Exploratory clinical trial to assess the role of Chandrashoor Lepidium sativum Linn as Balya in individuals with daurbalya

PDEAs College of Ayurved and Research center, Nigdi Pune-4110441 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To assess the effect of chandrashoor seeds ahaleev to increase bala that is strength of individuals with generalised weakness given for 2 months

研究概览

简要总结

1Title

Exploratory clinical trial to assess the role of Chandrashoor Lepidium Sativum Linn as Balya in individuals with daurbalya given for 2 months

2 Objective

Primary Objective

To assess the effect of Chandrashoor Lepidium SativumLinnas balya on individuals with daurbalya

  1. Methodology
I Study design  An exploratory clinical study
II. Study setting
Location of the study Ayurveda Hospital

Duration of study 18 months

III. Study population Volunteers male female of age group 18 to 40 yrs having complaints of daurbalya

 IV. Sample size

 Calculation

N=4pq/d2

P = proportion of individuals with daurbalya = 0.2

d = allowable error= 0.13

q=1-p 1-0.2=0.8

n= sample size

n=37

Sample size = 40

Total 40 volunteers will be taken

  V. Sampling technique Purposive Sampling technique

 VI . Method of selection of patient

 I****nclusion criteria

·         Volunteers of age group 18to40years

·         Volunteers with complaints of daurbalya assessed with Harvard Step Test.

·         Volunteers in the category of average to poor as per Harvard step test criteria

 Exclusion criteria

  1. Volunteers who are allergic to milk.

  2. In pregnancy and lactation

  3. Volunteers with pittapradhan prakruti.

  4. Volunteers having chronic diseases like diabetus mellitus hypertension tuberculosis malignancy and are known case of bleeding disorders hyperacidity

 Wi****thdrawal Criteria

1.      Volunteers not giving regular follow ups

2.      Volunteers who discontinue treatment more than 5 days will be withdrawn

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 40.00 Year(s)(—)
性别
All

入选标准

  • Volunteers of age group 18 to 40years Volunteers with complaints of daurbalya assessed with Harvard Step Test Volunteers in the category of average to poor as per Harvard step test criteria.

排除标准

  • Volunteers who are allergic to milk In pregnancy and lactation Volunteers with pita prakriti Volunteers having chronic diseases like diabetes mellitus, hypertension tuberculosis malignancy and are known case of bleeding disorders hyperacidity.

结局指标

主要结局

To assess the effect of chandrashoor seeds ahaleev to increase bala that is strength of individuals with generalised weakness given for 2 months

时间窗: To assess the effect of chandrashoor seeds ahaleev to increase bala strength of individuals with generalised weakness for 2 months

次要结局

  • NA(NA)

研究者

发起方
PDEAs College of Ayurved and Research center, Nigdi Pune-411044
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shivani Lonkar

PDEAs College of Ayurved and Research Center Nigdi Pune

研究点 (1)

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