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CTRI Number  CTRI/2024/07/071410 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparative Study of YuktiKrit Bala on Gym Members Protein Powder Versace Balya Mahakashaya Consumption in Relation to the Harvard Step Test  
Scientific Title of Study   A Physiological Comparative Study of Yuktikrit Bala on Gym Members Consuming Protein Powder or Balya Mahakashaya With Special Reference to HARVARD STEP TEST 
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 Ashok Kumar Sharma 
Designation  Professor and HOD 
Affiliation  Madan Mohan Malviya Government Ayurveda College 
Address  PG Department of Sharir Kriya first floor Madan Mohan Malviya Government Ayurveda College Amba Mata Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9413205904  
Fax    
Email  sharmadrak06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kumar Sharma 
Designation  Professor and HOD 
Affiliation  Madan Mohan Malviya Government Ayurveda College 
Address  PG Department of Sharir Kriya first floor Madan Mohan Malviya Government Ayurveda College Amba Mata Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9413205904  
Fax    
Email  sharmadrak06@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shruti Sharma 
Designation  PG Scholar 
Affiliation  Madan Mohan Malviya Government Ayurveda College 
Address  PG Department of Sharir Kriya first floor Madan Mohan Malviya Government Ayurveda College Amba Mata Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8239624003  
Fax    
Email  shrutisharma.bams@gmail.com  
 
Source of Monetary or Material Support  
PG department of Sharir Kriya first floor Madan Mohan Malviya Government Ayurveda College Hospital Udaipur Rajasthan India 313001 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurveda College 
Address  Amba Mata Udaipur 313001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shruti Sharma  Madan Mohan Malviya Government Ayurveda College  Madan Mohan Malviya Government Ayurveda College hospital opd no 3 Amba Mata
Udaipur
RAJASTHAN 
08239624003

shrutisharma.bams@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Madan Mohan Malviya Government Ayurveda College Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  gym going population 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Balya Mahakashaya, Reference: charak samhita sutra sthana chapter 4 shlok number 7, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: - milk), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: protein powder, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -250 ml milk), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Age 16 to 40 years
Both gender Male and Female
Healthy person
 
 
ExclusionCriteria 
Details  Age above 40 and less then 16
Pregnant women
Subjects with history of any chronic disease
Any anatomical deformity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
assessment of Bala harward step test  at base line 30 days 60 days 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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/ Phase 3 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

     NEED FOR STUDY:

Bala   is one of the  important  factors that  determine   Healthy life.  To regulate Bala, people opt physical exercises (vihaÌ„r) and consume various protein supplements (aÌ„haÌ„r) which give instant results but may be harmful  for health in long term. Information  on the consequences of protein   supplement use is  scarce   and  contradictory, as mentioned   in   many articles, i.e Whey protein supplementation and its potentially adverse effects on health: a systematic review.3

It is hard to digest hence; undigested protein may accumulate in body. Therefore, it is the identification of a kidney damage marker, such as microalbuminuria, excessive uric acid formation i.e gout. This can be resolved by using herbal āyurveda preparations i.e Balya Mahākaṣāya. Protein powder basically works on Māmsa Dhātu, while Balya Mahākashaya have 10 drugs that have different rasa, vīrya, vipāk, guna etc, It works on all Dhātu nourishment and is easily digestable.

It can enhance body strength and have drawbacks and also are pocket friendly as compared to other trending body building products. The motive is to guide the youth in right direction being an Āyurveda Doctor.

4.    HYPOTHESIS:

H0 - Balya Mahākaṣāya is not effective to increase Bala.

H1 - Balya Mahākaṣāya is effective to increase Bala.

5.    AIMS AND OBJECTIVE:

 

—  To study Bala.

—  To study Balya MahaÌ„kaá¹£aÌ„ya.

—  To study Harvard step test.

—  To study about Protein powders.

—  To compare the potency of Balya MahaÌ„kaá¹£aÌ„ya and protein powder in gym going members. 

6.    REVIEW OF PREVIOUS STUDY:

No research work has done in any institute or Āyurveda college related to present formulation in my knowledge. Some studies have been done on Bala and Harvard Step test.



 

7. LITERATURE REVIEW: 

The literary references will be collected from Library, Internet, Medical Journals and Research papers.


8.  MATERIALS AND METHODS:

Material

Material for literary study will be collected from Bṛihattrayi and Laghutrayī

Reference books of Human Physiology.

Various Research paper and articles.

Questionnaire for assessment of life style, Habits, History, Physiological symptoms

 

Method

 Clinical Study

·      Study Type- Clinical Study

·      Sampling Method- Simple Sampling

·      Subjects-  80

·      Days -      90 

Selection of subjects:

2 groups would be divided among 80 volunteers, each having 40 volunteer who are regular gym participants all over Rajasthan.

Group A  :   40 Healthy individuals who takes protein powder as supplement.

Group B : 40 Healthy individual who would be given Balya Mahākaṣāya granules as supplement (3-6 gm BD with milk).

 

Inclusion Criteria:

·       Age -   16-40 years

·       Both gender (Male/Female)

·       Healthy person

 

Exclusion Criteria:

·       Age > 40 and < 16.

·       Pregnant women.

·       Subjects with history of any chronic disease.

·       Any anatomical deformity.

Preparation of Balya Mahākaṣāya:

Balya Mahākaṣāya is one of the 50 Mahākaṣāya, which have been mentioned in Charak Samhita Sutra Sthana 4/7. Ten important drugs are enumerated under this Mahākaṣāya i.e. Aindr̄i, R̩ishabhī, Atirasā, R̩ishyaproktā, Payasyā, Ashwagandhā, Sthirā, Rohini̩, Balā and Atibalā.

  Powder of these drugs would be made to form granules of Balya MahaÌ„kaá¹£aÌ„ya in RasayanshaÌ„la.

Assessment of Bala-

According to Āchrya Charak,

                                         à¤¬à¤²à¤‚व्यायामशक्त्या (च.वि ४/८)

 It means Bala can be tested by physical activity. Hence, Harvard step test would be used to measure fitness. It measures the general capacity of body to cape with increased physical workload and ability to recover from it.

The fitness index was calculated with the help of following formula—

Fitness Index =     (Total Duration of exercise in seconds × 100)

                                       (Sum of 3 reading of pulse × 2)

Classification of physical fitness-

RATING

FITNESS INDEX

≥ 96

Excellent

83-96

Good

68-82

Average

54-67

Below average

≤54

Poor

Data Collection

Pre           -      0 Day

Post 1       -    30 days

Post 2       -    60 days

Post 3       -   90 days

 
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