Skip to main content
Clinical Trials/CTRI/2025/02/081355
CTRI/2025/02/081355
Not yet recruiting
Phase 2

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 site in 1 country40 target enrollmentStarted: March 10, 2025Last updated:

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

  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      Volunteers who discontinue treatment more than 5 days will be withdrawn

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

Sponsor
PDEAs College of Ayurved and Research center, Nigdi Pune-411044
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Shivani Lonkar

PDEAs College of Ayurved and Research Center Nigdi Pune

Study Sites (1)

Loading locations...

Similar Trials