Pharmaceutical (Nutraceutical) Development, Quality Control Assessment and Comparative Evaluation of Efficacy of a Polyherbal Compound for Muscle Gain in Gym Going Healthy Volunteers: A Study Protocol

Introduction: Protein powders are of great benefits for theyoungsterswho are gym freakand show an interest in bodybuildingneed some external supplementation for weight gain, in muscle growth.In Ayurveda several herbs are described which are useful in muscle gain.Large number of protein supplements are available in market, but in present times research based Ayurvedic herbal supplement which is having dual property like muscle strengthening and other side as a protein source is not yet available in market. Objective: Pharmaceutical Development, Quality Control Assessment and Comparative Evaluation of Efficacy of a Polyherbal Compound for Muscle Gain in Gym Going Healthy Volunteers. Study Protocol Shinde et al.; JPRI, 33(61B): 265-272, 2021; Article no.JPRI.78725 266 Methodology: Polyherbal compounds will be prepared with selected drugs like Ashwagandha, Vidarikanda, Arjuna, Gokshur, Sitaand it will be converted into churna form. Analytical study for standardization of Polyherbal compound will be done. Clinical evaluations for efficacy will bedonein gym going healthy volunteers. Observations and Results: Observation will be done on the basis of physical examination (assessment criteria) evaluation of the pre and post condition. Results will be drawn on the basis of observations and applying suitable tests. It will be noted and presented in form of table, charts, graphsetc. Conclusion: If this Pharmaceutical preparation of Herbal Compound shows expected and significant outcome in muscle growth and then it will be boon to the youngsters, bodybuilders who are in search of such Ayurvedicmuscle gain formulation.


INTRODUCTION
Ayurvedais the science of life, which deals with each and every aspect of life. Ayurveda places an emphasis on prevention and promotes health balance by emphasizing balance in lifestyle, nutrition, good thinking and the use of therapeutic herbs. Ayurveda knowledge aids in understanding how to achieve this balance of consciousness, mind and body according to their body constituents and preserve the improvements through lifestyle adjustments [1]. Everyone has a distinct fingerprint, and each person has a distinct pattern of energy. The combinations of emotional, mental and physical elements that make up a person's personality are reflected in their constitution. The constitution is already set by a number of elements at the moments of conception and remains the same throughout life [2]. Now a day's all youngsters are gym freak. They work hard to develop and sustain a lean, strong and well-defined physique and want some external supplementation for weight gain, in muscle growth [3].
Ayurveda has been with us for a very long time and has many advantages to shower on people.Ayurveda provides considerably safe and legal options to improve endurance, build muscle mass, body strength and increase physical stamina naturally [4]. Ayurvedic supplements benefits are likely stable and not decreasing even after discontinuing them [5]. Protein powder is a widely used dietary supplement. Protein is a necessary macronutrient for tissue repair, muscle growth, weight gain and the production of hormones and enzymes.Protein powders are of great benefits for the people who have an interest in bodybuilding or even people who want to lose weight and expecting muscle tone [6].
In Ayurveda several herbs are described which are useful in muscle gain. Several researches conducted on single drugs like Ashwagandha, Musalietc. have proven their muscle gain activity [7]. Research on Withaniasomnifera and Terminaliaarjuna revealed that Ashwangandha is effective in generalized weakness and to improve speed and lower limb muscular strength and neuro-muscular co-ordination while Terminaliaarjuna is effective in improving cardiovascular endurance and lowering systolic blood pressure [8].Tribulusterrestrisis also called as puncture vine commonly used in most of the Ayurvedic medicines that have become a popular bodybuilding supplement [9]. Ginseng is one of the most studied herb for human physical performance and popular herbal dietary supplements worldwide [10].term ginseng usually refers to the species Panax ginseng. Ginseng is available in many forms: whole root, rootpowder, steamed root powder, teas, tinctures and standardizedroot extracts [11].
Ayurveda holds the concept of Brinhanafor overall growth of the body and potentiating the strength, energy and stamina in the healthy individuals. Despite their long tradition of use by a physically active person herbs have seldom been studied for scientifically as possible aid to physical performance. Except for the few studies still there is a dearth of scientific studies on the effect on herbs and herbal extracts on human physical performance. Generally athletes, sport persons, wrestlers consume herbs to enhance their long-term endurance performance. Hence in the present study attempt is made to generate scientific evidence of herbal compound as ergogenic aids for youngsters to enhance the physical strength and performance who exercise [12].

Justification
Large number of protein supplements are available in the market, but in present times research based Ayurvedic herbal supplement which is having dual property like muscle strengthening and other side as a protein source is not yet available in the market. Protein supplement plays major role in weight gain and muscle growth and recovery. There is no information available regarding Ayurveda compound herbal supplement having this dual property. Hence there is a strong need to develop herbal compound.

1.
To develop the SOP of Ayurvedic Polyherbal Compound.

2.
To access the quality control parameters of Polyherbal Compound.

3.
3.To compare the efficacy of Polyherbal compound with standard protein compound (Muscleblaze Super Gainer).

4.
To evaluate the efficacy of Polyherbal compound in Muscle growth & BMI in gym going healthy volunteers.

MATERIALS AND METHODS
Present (Suggested) work will be conducted under the following headings:

Study Design
This study is related to drug preparation in which three different batches of Polyherbal compound will be prepared to establish pharmaceutical standardization. Pharmaceutical study will be done in following steps; • Procurement of Raw materials: All required raw materials will be procured from field and authentic reliable sources.

Drug collection and authentication:
•

Selection of Volunteer / Screening
After a physical examination and complete blood count (CBC), FBS, LFT, RFT, T3 T4 TSH, Lipid Profile, and blood pressure with normal values, volunteers aged 20 to 30 years old will be chosen.

Size
To find out therapeutic potential of this Polyherbal compound the study will be conducted on 60 volunteers (30 in each group).

Methodology
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table.
Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups. In one group (30 participants) we will be given Muscleblaze (muscle toner) as a standard drug and other group (30 participants) will receive Polyherbal compound for 6 weeks with day wise schedule of exercises. Dose will be 12 gm each with cow's milk advised to be taken at evening. Protein content will be calculated for both the drugsBefore and after treatment photographic evaluation will be done. After inclusion in study protocol each participant will receive the respective treatment from day one for 6 weeks. A container of 1kg Polyherbal compound will be given to them. Instruction regarding to consumption will be given to each participant. Telephonic reminder will be given for taking the dose timely. In person follow up will be taken on 15th, 30th and 45 th day. After completing the treatment for 6 weeks, each participant will be evaluated using Ayurvedic and modern parameters. Individuals, who will miss even 1 application of drug in total 45 days, will be dropped out from the clinical study. Post treatment follow up will be taken for next 6 weeks.

Research Outcome
Observations will be noted and presented in the form of Tables, charts, photographs etc.

Statistical Analysis
Statistical analysis will be done by applying Pair and Unpaired "t" Test, One way ANOVA and suitable descriptive statistical tests.

DISCUSSION
Present research focuses on the tenets of BhaishajyaKalpanato evaluate a new Polyherbal compound for muscle gain. The basic Ayurvedic principles of ease of availability (natural abundance), cost effectiveness, and easily consumable,keeping in consideration the demands of current lifestyle trends and youngster's preferences will be followed to provide a holistic remedial for weight gain, increasing muscle gain & strength, body tone, flexibility of body. The intended ingredients in the formulation are Ashwagandha, Vidarikanda, Arjuna, Gokshur and Suger. This formulation has been devised in accordance with the overarching guiding principles of Ayurveda that encourage individual preference and ease of preparation and consumption.The methodology of formulation and preparation will follow the procedures outlined in texts diligently [17]. Considering current lifestyle and trending preference amongst Youngster's a standardized formulation will be prepared. The churna form is easier to carry and consumption, and also has a better shelf life [18].
The efficacy of the drug will be tested by comparing the effect of the drug with standard drug with pre and post assessment in Muscle gain. The dosage and frequency will be suggested at the outset and following clinical assessment, the researcher expects to establish the efficacy, acceptability and outcome of the Polyherbal compound. Studies on efficacy of different Ayurvedic preparations were reported [19][20][21]. Few of the related studies were reviewed. There are many protein formulations of herbal origin available in the market. Research work also available on single drugs such as Ashwangdha, Shatavari, Musali, Vidarikanda to test the efficacy of muscle tone. But there is no any research work available on combination of drugs which are used as herbal supplement in gym going healthy volunteers. On literature search, few drugs have shown some characteristic features. Gokshur is having tremendous effect in decreasing exercise related fatigue [22][23][24], Arjuna is also found useful in gaining aerobic exercise capacity [8]. No such formulation is available and developed previously hence considering the actions of these drugs in enhancing the muscle tone and muscle strength new formulation is planned and its action sought in gym going healthy going volunteers.

CONCLUSION
If this Pharmaceutical preparation of Herbal compound shows expected and significant outcome in muscle growth then youngsters, bodybuilders can be used research base Ayurvedic Herbal compound in day to day life. If this herbal compound found to be effective in enhancing human physical performance then it will open a new era for another such studies.

NOTE
The study highlights the efficacy of "Ayurveda" which is an ancient tradition, used in some parts of India. This ancient concept should be carefully evaluated in the light of modern medical science and can be utilized partially if found suitable.

CONSENT
As per international standard or university standard, respondents' written consent will be collected and preserved by the author(s).

ETHICAL APPROVAL
It is not applicable.