Evaluation of Bruhaniya Effects of Kushmanda Granules and Ashwagandha Granules in Karshya: A Randomised Controlled Trial Protocol

1. PG Scholar, Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 2. Professor, Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 3. PG Scholar, Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India. 4. PG Scholar, Department of Kayachikitsa, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India.

Abstract

Introduction: Ayurveda asserts that a healthy diet can prevent many health issues. Food is essential as a source of nutrition and possesses significant medicinal value. Nutritional deficiencies, often referred to as undernutrition, arise from insufficient dietary intake. Karshya is a condition in which an individual's body becomes emaciated, characterised by a reduced quantity of rasa dhatu, leading to a state of Mamsahinata or Manskshaya.

Need for the Study: Many individuals experience a lack of confidence and depression due to their emaciated condition. Various nutritional and bulk-promoting products available in the market are often very costly. Ashwagandha is commonly used by Ayurveda practitioners for its Bruhan effect. Although Kushmanda is mentioned as Bruhaniya in the Bhavaprakash Nighantu, there have been very few studies conducted on it. Since Kushmanda is more economical than Ashwagandha, research is needed to explore this cost-effective bulk-promoting medicine.

Aim: To conduct a comparative evaluation of the Bruhaniya (bulk-promoting) effects of Kushmanda granules (Benincasa hispida) and Ashwagandha granules (Withania Somnifera Linn.) in cases of Karshya (Undernutrition).

Materials and Methods: A single-blinded, randomised controlled trial will be conducted at the Department of Kayachikitsa, Mahatma Gandhi Ayurveda College Hospital and Research Centre (MGACHRC), Salad Hirapur (H), Maharashtra, India, from October 2023 to September 2024. A total of 60 subjects will be divided into two groups for the present study, with 30 subjects in each group. In Group A, Trikatu Churna will be administered in doses of 2 grams once a day with lukewarm water for the first seven days, followed by Ashwagandha granules in doses of 10 grams with milk twice a day for 90 days. In Group B, 2 grams of Trikatu Churna will be given once a day with lukewarm water for the first seven days, followed by Kushmanda granules in doses of 10 grams with milk twice a day for 90 days. Assessments will be made on the 0, 30th, 60th, and 90th days. The assessment will be based on improvements in body weight, Body Mass Index (BMI), and arm and waist circumference. Statistical analysis will be performed using Statistical Package for the Social Sciences (SPSS) version 22.0, and the statistical tests applied will include the Chi-square test, Wilcoxon’s rank sum test, and Wilcoxon’s signed rank test, with a significance level set at 0.05.

Dietary supplements, Durbala, Emaciation, Nutrition, Rasa dhatu

Nutrition-related diseases are a significant global health concern. They can arise from overnutrition, resulting in obesity (Sthaula) in developed countries, or from undernutrition, leading to underweight individuals (Karshya) in developing countries. According to the World Health Organisation (WHO), in 2016, the prevalence of underweight individuals among adults, defined as those with a BMI below 18.5, was recorded at 22.6% for males and 24.1% for females (1). Nutritional inadequacies are a widespread problem among adolescents, causing them to lose weight (Krusha) and become physically and intellectually feeble (Durbala). The adverse effects of lifestyle changes impact the adolescent population (2),(3),(4).

Karshya is a condition in which a person’s body becomes emaciated, resulting in a reduced quantity of rasa dhatu, further causing a state of Manskshaya (loss of muscle tissue). Acharya Dalhana commented on Karshya, stating, “Karshyam Mamsakshayam” (In undernutrition, there is a loss of muscle tissues in the body) (5). The word ‘Krush’ is derived from the root ‘Krush Tanukarane’ with the suffix ‘Acha Pratyaaya’. According to Acharya Charaka, Karshya is an Apatarpana janya vyadhi (disease caused by insufficient food intake), which is described as a Vata nanatmaja vikara. It is included in the ‘Ashtanindaniya purush’ (eight socially undesirable physical states) (6). According to Acharya Charaka, poor food intake is the main cause of Karshya. Individuals with Krush experience wasting (causing decay or loss of strength) in the buttocks, belly and neck, along with a noticeable vascular network, prominent skin and bones, and thick nodes (7). They may also suffer from shwasa (dyspnoea), gulma (tumours), arsha (haemorrhoids), rakatpitta (haemorrhagic diseases), and disorders related to vata (8). Karshya is classified as a vata pradhan vyadhi (undernutrition caused by an imbalance of vata dosha). Bruhan is one of the Shadvidh Upakrams specifically described as bulk-promoting therapy, which is advocated in classical texts for its management (9).

A person who receives Bruhan (bulk-promoting) therapy benefits both physically and psychologically, enhancing their overall health and stamina. Kushmanda (Benincasa hispida Cogn.) is mentioned as Bruhaniya (bulk-promoting) in Bhavaprakash Nighantu (10) and is well known for promoting bodily strength and providing nutrition to all metabolic processes (Dhatus), thus fulfilling the principle of Bruhan (bulk-promoting).

Although Kushmanda is mentioned as Bruhaniya in Bhavaprakash Nighantu, very few studies have been conducted on it. Given that Kushmanda is more economical than Ashwagandha, research is required to explore this cost-effective bulk-promoting medicine. Hence, the present study aims to evaluate the comparative Bruhaniya (bulk-promoting) effects of Kushmanda granules and Ashwagandha granules in cases of Karshya.

Primary objectives:

• To assess the effect of Kushmanda granules on body weight, BMI, and arm and waist circumference in subjects with Karshya.
• To assess the effect of Ashwagandha granules on body weight, BMI, and arm and waist circumference in subjects with Karshya.

Secondary objectives:

• To compare the effects of Kushmanda granules and Ashwagandha granules on body weight, BMI, and arm and waist circumference in subjects with Karshya.

Null Hypothesis (H0):

• Kushmanda granules will have no Bruhaniya (bulk-promoting) effect compared to Ashwagandha granules in subjects with Karshya.

Alternative Hypothesis (H1):

• Kushmanda granules will have a Bruhaniya (bulk-promoting) effect similar to that of Ashwagandha granules in subjects with Karshya.

Review of Literature

According to Acharya Charaka, excessively lean individuals (Atiruksha) are considered despicable due to their lack of strength and vitality, making them susceptible to various diseases and environmental stressors (11). Kushmanda is traditionally known for its Bruhaniya (bulk-promoting) properties, suggesting that it might aid in weight gain. Ashwagandha is renowned for its Rasayana (rejuvenating) and Bruhaniya (bulk-promoting) properties, which may contribute to overall weight gain in individuals suffering from Karshya. The clinical study conducted by Mishra RK et al., found that both forms of Ashwagandha demonstrated significant improvements in the participants’ overall health, muscle strength, and endurance (12). The use of Ashwagandha Ghrita and granules was associated with enhanced physical vitality, weight gain in underweight individuals, and improved energy levels. Additionally, participants reported better mental health and reduced stress levels, corroborating Ashwagandha’s adaptogenic properties.

The study conducted by Dutt SS et al., found that Ashwagandha Rasayana significantly improved various markers of nutritional status, including weight gain, in the participants (13). The treatment was well-tolerated, and no adverse effects were reported, indicating its safety and efficacy as a therapeutic intervention for underweight conditions. Another study conducted by Mhatre S et al., found that Brumhanatherapy, which includes dietary and herbal interventions designed to build body tissue and promote growth, resulted in significant improvements in BMI and the overall nutritional status of the participants (14). The therapy led to increased body weight and improved health markers, indicating its effectiveness in managing low BMI conditions. A critical review on Karshya by Ketaki L et al., concluded that Karshya, characterised by emaciation and under-nutrition, can be effectively managed using Ayurvedic principles (15). Ayurvedic interventions such as Brimhana (nourishing) therapies are found to be particularly beneficial in treating Karshya.

Methodology

A single-blinded, randomised controlled trial will be conducted at the Department of Kayachikitsa, Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Salod Hirapur (H), Maharashtra, India, from October 2023 to September 2024. The study has obtained ethical clearance from the Institutional Ethical Committee of DMIHER, Wardha, Maharashtra, India, under the number MGACHRC/IEC/July-2022/550. The Clinical Trials Registry-India (CTRI) registration number is CTRI/2023/01/049305. Before conducting the trial, subjects will be asked to sign an informed consent form in their native language, explaining all the details of the study. Participant personal data will be collected and kept confidential before, during, and after the trial. The committee will oversee the trial’s progress and determine its conclusion. Any adverse events will be evaluated by the researcher and reported to the ethics committee. Data will be stored in a secure location to which only the researcher will have access. To prevent bias in the study, a second person will code and assign subjects to opaque, sealed envelopes with sequential numbers for Groups A or B {Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) scheme}.

Inclusion criteria:

• Subjects who provide written informed consent;
• Age between 20 and 40 years of either sex;
• Subjects with a BMI less than 18.5 kg/m2.
• Subjects with Haemoglobin (Hb) levels greater than 8 gm/dL.

Exclusion criteria:

• Pregnant and lactating women.
• Individuals with anaemia
• Known cases of cirrhosis of the liver, pancreatitis, tuberculosis, diabetes mellitus, diabetes insipidus, hyperthyroidism, or other systemic diseases like Chronic Kidney Disease (CKD), Congenital Heart Disease (CHD) and other immuno-compromised diseases like Human Immunodeficiency Virus (HIV), rheumatoid arthritis, etc.,

Sample size calculation:

n1=n2 =(Z_α+Z_β)²σ²/ (δ)²

Z_α=1.96 at 5 % errorr and CI at 99 %
Z_β=1.64= Powerat 95%

The sample size is calculated based on the difference in mean values for the BMI as the primary variable between pre- and post-treatment, while considering the standard deviation.
Formula using mean difference:

Mean difference {in BMI (Post-Pre) in group= 1.23 (13)}

Pooled Standard deviation= (1.21 +1.11)/2 = 1.16

= (1.96 + 1.64) ^2 (1.23) ^2/ (1.16) ^2 = 24

The minimum sample size required is 24 participants per group. Considering a 20% dropout rate, this results in an additional 6 participants, bringing the total sample size required to 30 participants per group.

Study Procedure

Study setting: Subject selection will primarily take place from the Wardha district population, which includes individuals from all communities in Maharashtra, India, as well as from the Kayachikitsa Outpatient Department (OPD) and Inpatient Department (IPD) of the MGACHRC, Salod (H), and peripheral camps. The total sample size for this study will comprise 60 participants, divided evenly into two groups: Group A: Ashwagandha Granules (30 participants) and Group B: Kushmanda Granules (30 participants). In both groups, subjects will be given 2 grams of Trikatu Churna once a day with lukewarm water for the first seven days, followed by Ashwagandha Granules in Group A and Kushmanda Granules in Group B for a duration of 90 days. All parameters will be recorded at baseline (Day 0), and on the 30th, 60th, and 90th days.

Drug collection/authentication and preparation: The raw materials for the drugs will be purchased from an authentic shop in Nagpur (Wagh Brothers) and will be identified by the departments of Dravyaguna and Rasashastra at MGACHRC, Salod, Wardha.

• Kushmanda granules: The formulation of Kushmanda granules is based on Srivastav S and the Sharangadhara Samhita (Table/Fig 1) (16). Freshly picked Kushmanda fruits will be chopped into small pieces, the seeds and hard outer layer will be removed, and the pieces will be placed in a cooker with twice the amount of water and steamed. To extract the juice, the pulp will be mashed into a soft mass and then squeezed through a clean cloth. Next, the pulp will be cooked over medium heat in Go-ghrita (cow’s ghee) until it turns a brownish colour. An equal amount of sugar candy will be added to the paste. After adding Prakshepa Dravya and the fried paste, the mixture will be vigorously blended and continuously stirred until granules form.

• Ashwagandha granules: The formulation of Ashwagandha granules is derived from Srivastav S and Sharangdharsamhita (Table/Fig 2) (16). Fresh or dried Ashwagandha roots will be thoroughly cleaned and then left to dry in the sun for several days. Once dried, the roots will be ground into a powder using a pestle and then sieved. Eight times the amount of water will be added to the quantity of powder, and the mixture will be heated until one part of the entire mixture remains. After this, some Go-ghrita and an equal amount of sugar candy will be added to the kwath. Following the addition of Prakshepa Dravya, the mixture will be vigorously stirred until granules form.

Ingredients of Ashwagandha Granules:

Outcomes:

The screening parameters for this study will include a Complete Blood Count (CBC).

Objective parameters, including body weight, BMI, and body circumference (arm and waist), will be assessed on the 0, 30th, 60th, and 90th days (Table/Fig 3). The objective parameters for this study will be:

• Body weight: Measured using a standard weighing machine.

• BMI: Calculated using weight in kilograms divided by the square of height in metres (17).

• Body circumference: Measured using a standard measuring tape in centimetres, with measurements taken 4 cm above both arms and at the mid-umbilicus for waist circumference.

Statistical Analysis

The data will be analysed using SPSS version 22.0. The results will be assessed based on objective parameters, including improvements in body weight, BMI, arm circumference, and waist circumference. Qualitative variables will be compared using a Chi-squared test. An independent t-test will be used to compare the means of the two groups when the data follows a normal distribution, while a paired t-test will be employed for comparisons of before and after data. Wilcoxon’s rank sum test and Wilcoxon’s signed rank test will be applied, with a significance level set at 0.05.

Intervention modification: Any negative side-effects will be documented and reported to the ethics committee during the treatment. Subjects will receive treatment for any unfavourable outcomes. Participants will be asked to state their desire to withdraw from the treatment along with their reasons for doing so.

Guidelines: This protocol will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

Gantt chart: A quarterly-based Gantt chart will be included, as it is relevant only for long-term projects, including postgraduate and PhD synopses.

Data monitoring: A formal committee will oversee data monitoring.

Dissemination: This protocol will be published as a thesis to disseminate the study for Karshya. A complete overview of the study’s design, methodology, data collection techniques, data analysis strategy, and ethical considerations is provided in the study protocol (Table/Fig 4). We hope that by making this protocol available, future research through posters, papers, and publications will be facilitated, thereby advancing knowledge in the field.

Acknowledgement

The authors acknowledge the scholars whose articles are referenced and mentioned in the manuscripts for their invaluable assistance. The writers also thank all of the authors, editors, and publishers of the books, journals, and papers that will be used in the evaluation and discussion of the literature for this work.

DOI and Others

DOI: 10.7860/JCDR/2024/69926.20229

Date of Submission: Feb 03, 2024
Date of Peer Review: Jun 19, 2024
Date of Acceptance: Jul 25, 2024
Date of Publishing: Nov 01, 2024

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

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