An Exploratory clinical trial to assess the role of Chandrashoor Lepidium sativum Linn as Balya in individuals with daurbalya
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- PDEAs College of Ayurved and Research center, Nigdi Pune-411044
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To assess the effect of chandrashoor seeds ahaleev to increase bala that is strength of individuals with generalised weakness given for 2 months
Overview
Brief Summary
| 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
- 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
-
Volunteers who are allergic to milk.
-
In pregnancy and lactation
-
Volunteers with pittapradhan prakruti.
-
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 Volunteers who discontinue treatment more than 5 days will be withdrawn
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To assess the effect of chandrashoor seeds ahaleev to increase bala that is strength of individuals with generalised weakness given for 2 months
Time Frame: To assess the effect of chandrashoor seeds ahaleev to increase bala strength of individuals with generalised weakness for 2 months
Secondary Outcomes
- NA(NA)
Investigators
Dr Shivani Lonkar
PDEAs College of Ayurved and Research Center Nigdi Pune