| CTRI Number |
CTRI/2025/02/081355 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to assess the role chandrashoor seeds (ahaleev) to increase bala i.e strength of individuals with generalised weakness. |
|
Scientific Title of Study
|
An Exploratory clinical trial to assess the role of Chandrashoor Lepidium sativum Linn as Balya in individuals with daurbalya |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Lonkar |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurved and Research Center Nigdi Pune |
| Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurved and Research center, Nigdi Pune-411044
Maharashtra
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8999670836 |
| Fax |
|
| Email |
shivanilonkar04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arti Firke |
| Designation |
BAMS MD PhD Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research Center Nigdi Pune |
| Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurved and Research center, Nigdi Pune-411044
Maharashtra
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8888845674 |
| Fax |
|
| Email |
arfirke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arti Firke |
| Designation |
BAMS MD PhD Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research Center Nigdi Pune |
| Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurved and Research center, Nigdi Pune-411044
Maharashtra
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8888845674 |
| Fax |
|
| Email |
arfirke@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research center, Nigdi Pune-411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research center, Nigdi Pune-411044 |
| Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurved and Research center, Nigdi Pune-411044 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivani Lonkar |
Ayurved Rugnalaya and Sterling Multispeciality Hospital |
Ayurved Rugnalaya and Sterling Multispeciality Hospital
sector no. 27, department of swasthavritta and yoga room no 123B nigdi pradhikaranpune-411044
Pune
MAHARASHTRA |
8999670836
shivanilonkar04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Standard Operating Procedure for Institutional Ethical Committee-I Human Research at Pune District Education Associations College of Ayurved and Research Center Pune |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
generalised weakness |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandrashoor, Reference: Bhavprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Cow milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of chandrashoor seeds ahaleev to increase bala that is strength of individuals with generalised weakness given for 2 months |
To assess the effect of chandrashoor seeds ahaleev to increase bala strength of individuals with generalised weakness for 2 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 Sativum Linnas balya on individuals with daurbalya 3. 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 Inclusion 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 Withdrawal Criteria 1. Volunteers not giving regular follow ups 2. Volunteers who discontinue treatment more than 5 days will be withdrawn | |
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