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临床试验/CTRI/2024/07/071410
CTRI/2024/07/071410尚未招募2/3 期

A Physiological Comparative Study of Yuktikrit Bala on Gym Members Consuming Protein Powder or Balya Mahakashaya With Special Reference to HARVARD STEP TEST

Madan Mohan Malviya Government Ayurveda College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
assessment of Bala harward step test

研究概览

简要总结

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:

 Â—  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 Bṛ*ihattrayi 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 Mahākaṣāyai.e. Aindr̄i, R̩ishabhī, Atirasā, R̩ishyaproktā, Payasyā, Ashwagandhā, Sthirā, Rohini̩, Balā and Atibalā.

Powder of these drugs would be made to form granules of Balya Mahākaṣāya in Rasayanshāla.

Assessment of Bala-

According to Āchrya Charak,

बलंव्यायामशक्त्या **(च.**वि४/८)

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

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Age 16 to 40 years Both gender Male and Female Healthy person.

排除标准

  • Age above 40 and less then 16 Pregnant women Subjects with history of any chronic disease Any anatomical deformity.

结局指标

主要结局

assessment of Bala harward step test

时间窗: at base line 30 days 60 days 90 days

次要结局

未报告次要终点

研究者

发起方
Madan Mohan Malviya Government Ayurveda College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ashok Kumar Sharma

Madan Mohan Malviya Government Ayurveda College

研究点 (1)

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