A randomized open-label comparative clinical study of effect of lifestyle modification and Shatapushpadya Churna on Agnimandya.

BACKGROUND: Non-communicable diseases are expected to kill more people in the 21st century which are the resultant of deranged lifestyle such as unhealthy dietary habits and wrong behavioral pattern. In Ayurveda, Ahara Vidhi (dietary rules) and Vihara (conducts) are described in detail which can be included under the heading of lifestyle. Agnimandya (indigestion) is considered as the root cause of all diseases like diabetes mellitus, obesity etc., which are few among the top ten lifestyle disorders. AIM: The present study is aimed at establishment of relationship between disturbances in lifestyle and Agnimandya and role of lifestyle modification in correcting the state of Agnimandya.
MATERIALS AND METHODS: The present study was carried out on 33 patients diagnosed with Agnimandya having disturbed lifestyle. Patients were divided into two groups with simple random sampling method. In Group A, lifestyle modification was advised with placebo capsules of wheat flour, while in Group B, patients were treated with 2 g of Shatapushpadya Churna for 2 weeks.
RESULTS: Both the groups showed statistically highly significant results on majority of the symptoms of Agnimandya, however, Group A provided better effect than Group B.
CONCLUSION: Lifestyle has definite role in the manifestation and treatment of Agnimandya.

RCT Entities:   Population Interventions Outcomes

Introduction

In a major shift of disease pattern, WHO has found that non communicable diseases are expected to kill 38 millions of people each year. Major risk factors under this umbrella are mainly lifestyle related conditions such as physical inactivity, unhealthy diet, and disturbed sleep pattern[1] which are preventable. Hence, more attention has to be given to prevent these lifestyle related diseases. In classics, there are references of 100 years life span of the people who are accustomed with proper diet and regimen.[2] Nowadays, due to disturbed lifestyle, i.e., faulty dietary habits and wrong behavioral pattern, life expectancy of male/female has been decreased to 67/70 years.[3]

Lifestyle means a way in which a person lives, which includes entire activities and conducts by a person during the whole day, night and its methods, timing, place, etc. Hence, Vihara and Ahara Vidhi can be included under the heading of lifestyle in Ayurveda. Vihara consists of conducts explained under the heading of Dinacharya (daily regimen), Ritucharya (seasonal regimen) and Sadvritta (behavioral regimen) and Ahara Vidhi (dietetic rules) consists of the conducts given under the heading of Ahara Vidhi Vidhana (codes of dietetics), Bhojanottara Vidhi Vidhana (conducts after meal) etc., which are described in detail in Ayurveda. Any alteration in these conducts leads to the manifestation of diseases.

Wrong dietary habits such as Adhyashana (eating after meal), Vishamashana (diet on irregular time and quantity), and wrong behavioral pattern such as Vegadharana (suppression of urges) leads to vitiation of Doshas independently or together causing Agnimandya (indigestion). In Ayurveda, it is believed that Agnimandya is the root cause for all the diseases[4] such as Prameha and Sthaulya. In modern science also, it has been proved that there exists gut-brain-endocrine axis which involves ghrelin-leptin hormones, insulin and orexins. Disturbance in this axis leads to diseases such as obesity and diabetes mellitus which are among the top ten lifestyle disorders. The causes for these diseases are improper diet pattern, disturbed sleep pattern etc.[56]

The present study is aimed at establishment of relationship between disturbances in lifestyle and Agnimandya and role of lifestyle modification in correcting the state of Agnimandya by correcting impaired Ahara Parinamakara Bhavas (factors responsible for digestion) and circadian rhythm. Therefore, in this study, Agnimandya caused by disturbed lifestyle has been selected and in one group, lifestyle modification has been suggested. In the other group, Shatapushpadya Churna was selected for comparison, as most of the contents have Katu Rasa (pungent taste), Katu Vipaka and Agnidipana (digestion improving) property.

Materials and methods

Patients attending the O.P.D. of Basic Principles with symptoms of Agnimandya and fulfilling the criteria of inclusion were selected for the present study. An elaborative case taking proforma was specially designed for the purpose of incorporating all aspects of the disease and lifestyle related to the disease in Ayurveda.

The present study was done as a randomized open-labeled clinical trial. The study was cleared by the Ethical Committee of the Institute for Postgraduate Teaching and Research in Ayurveda. Informed written consent was taken from each patient before starting the study. The study was registered in the Clinical Trial Registry of India (no.: CTRI/2014/02/004420).

Inclusion criteria

Patients with symptoms of Agnimandya such as Ajeerna (indigestion), Atilalasrava (hyper salivation), Aruchi (dislike of food), Adhmana (heaviness of abdomen), Vibandha (constipation), and Chardi (vomiting)[78]

Patients between 15 and 60 years of age of either sex.

Exclusion criteria

Patients suffering from any systemic diseases such as hypertension, and diabetes mellitus

Patient having any established pathology of gastrointestinal tract

People performing night duty for long time and who can’t change their lifestyle.

Investigations

Hemoglobin%, total leukocyte count, differential leukocyte count, erythrocyte sedimentation rate, total red blood cells, routine and microscopic examination of urine, and routine & microscopic examination of stool were done before initiating the treatment to rule out other pathology.

Grouping and posology

The study was conducted in 33 diagnosed patients of Agnimandya. They were randomly divided in to two groups. In Group A, lifestyle modification was advised along with two placebo capsules of wheat flour 250 mg twice daily with lukewarm water with the meal for 2 weeks. In Group B, two grams of Shatapushpadya Churna was administered twice daily with lukewarm water with the meal for 2 weeks. The contents of Shatapushpadya Churna[9] are Shatapushpa (Anethum sowa Kurz.), Vidanga (Embelia robusta C.B. Clarke, non-Roxb.), Maricha (Piper nigrum Linn.), and Saindhava (Sodii chloridum).

Criteria for evaluation of lifestyle disturbance [Table 1]

Evaluation of lifestyle disturbance related to the disease Agnimandya was made on the basis of scoring and gradation pattern which includes dietetic rules and conducts during and after meal which are described in Ayurveda. Criteria for total assessment of lifestyle disturbance is mentioned in Appendix 1.

Criteria for gradation: Scoring and Gradation for assessment of Lifestyle

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Criteria for assessment of effect of therapy [Table 2]

Improvement in Agnimandya after treatment was assessed on the basis of improvement in chief complaints, Abhyavaharana Shakti (food intake capacity), Jarana Shakti (digestive capacity) and Mala Samata (improperly formed feces) by scoring and gradation pattern. Gradations for assessment of effect of therapy are mentioned in Appendix 2.

Scoring and Gradation of symptoms of Agnimandya

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Observations and discussion

The present study reveals that among 30 completed patients, 42.5% were between 31 and 40 years and 33.27% were between 21 and 30 years. This may be because, these people have hectic works schedule and have more family responsibilities. They are less concerned with their health and are following improper dietetic and behavioral regimen, resulting in impaired digestive power. 51.3% of the patients diagnosed were males and they had this disease due to their irregular food pattern during their works schedule, 32.4% of the patients diagnosed were employees and this was because they were exposed to untimely and unhealthy food habits due to their increased work load.

Observations related to conducts

Lack of exercise and sitting type of work were found in 87.9% and 64.5% of patients respectively. It is a major cause for vitiation of Kapha[10] which hampers the digestion. Vigilance at night was found in 57.9% of the patients. It leads to vitiation of Samana Vata[11] and Agni.[12] In human body, there exists a circadian rhythm and is must for activities of digestive enzymes. Wakefulness at night causes disruption in circadian rhythm and disturbance in activities of digestive enzymes which leads to indigestion.[13] Day time sleep was found in 85.1% of the patients which leads to vitiation of Kapha and hampers digestive power.[111415] Suppression of urge of micturition and defecation was found in 51.1% of patients and suppression of hunger was found in 45.4% of patients. It leads to vitiation of Apana Vata which further leads to vitiation of Samana Vata and hampers digestion.[1617]

Observations related to dietary habits

Intake of food for four times per day was found in 48.2% of patients. It results in mixture of immature Rasa with the product of food taken after ward, resulting in the provocation of all the Doshas instantaneously.[10] Irregular breakfast, lunch and dinner were found in 72.4%, 57.2% and 50.7% patients respectively, which disrupts the normal digestive pattern adhered to a circadian rhythm.[18] Intake of non vegetarian food, curd and oily foods during night time was found in 23.8% of the patients. Intake of cold drinks and cold butter milk at night was found in 30.2% and intake of milk at night was found in 23.6% of the patients. At night, there is decrease in the function of all systems of body. Therefore, food items which are difficult to digest and sticky, for example, non-vegetarian foods, curd,[19] milk,[20] oilyfood[21] during night time causes improper digestion. Intake of cold food was present in 63.6% of patients. It results in indigestion due to lack of Ushnata (heat), which is one of the Ahara Parinamakara Bhava[22] essential for proper digestion of food.

Intake of more quantity of food was found in 79.2% of the patients and intake of food when previous food is not digested were found in 56.8% of the patients. When food is being taken in more quantity, it can’t be digested properly due to improper functioning of Vayu.[22] Performing different activities such as watching TV, internet chatting, answering phone calls and operating computer etc., during meals was found in 90.1% and talking during meals was found in 84.7% of the patients. The quantity of the meal exceeds the normal limit in these cases which results in over eating which badly affects their digestive power.[23]

Observations about water drinking habits

Intake of more quantity of water was found in 47.8% of patients. Excess dilution of the gastric contents lows down digestion.[24] Habit of taking of large quantity of water after meal was present in 90.2% of patients. Normally, abdominal muscles relax after consumption of food and water, to accommodate ingested substances and help in digestion. Excessive intake of water after taking meal can result in prolonged abdominal muscle relaxation[25] which in turn can cause indigestion. Intake of large quantity of water before meal was found in 23.5% patients. It leads to dilution of the HCl, resulting in decrease in digestive power.[26]

Markly disturbed, moderately disturbed and mildly disturbed lifestyle was found in12.1%, 81.8% and 6% of the patients of Agnimandya, respectively. Habit of intake of large quantity of water in morning, i.e., after sunrise was present in 63.4% patients. Acharya Bhavamishra[27] has advised to drink water in the last part of night who has predominance of Vata in the body. If one drinks water in this period, it helps in the easy passage of the stool. In the morning, after sunrise, Kapha is dominant in the body. Intake of excess water in this period leads to vitiation of Kapha. Intake of large quantity of water at night was found in 81.4% patients, which also leads to vitiation of Kapha.[28]

Observations about symptoms of Agnimandya

The symptoms such as indigestion, heaviness in abdomen, and dislike for food were present in all the patients, while hyper salivation was found in 90% of the patients. Constipation was present in 96.7% and vomiting was present in 53.3% of the patients. Avara Jarana Shakti was found in 69.69% patients and Avara Abhyavaharana Shakti was found in 72.72% of the patients.

Results

In Group A (lifestyle modification), statistically, highly significant results was found in all the chief and associated complaints of Agnimandya such as indigestion (82.22%), heaviness of abdomen (95.56%), hyper salivation (84.52%), dislike of food (86.67%), and constipation (92.86%). Significant result was found in vomiting (87.5%) [Table 3]. Significant improvement was found in Abhyavaharana Shakti (76.06%) [Table 4], Jarana Shakti (89.47%) [Table 5] and Mala Samata (91.57%) [Table 6].

Table 3

Effect of lifestyle modification (Group A) on complaints of Agnimandya (n=15)

Table 4

Effect of lifestyle modification (Group A) on Abhyavaharana Shakti (n=15)

Table 5

Effect of lifestyle modification (Group A) on Jarana Shakti (n=15)

Table 6

Effect of lifestyle modification (Group A) on Mala Samata (n=15)

In Group B (Shatapushpadya Churna), statistically, highly significant results was found in all the symptoms of Agnimandya such as indigestion (55.56%), heaviness of abdomen (72.22%), hyper salivation (73.08%), dislike of food (65.56%) and constipation (85.6%). Significant result was found in vomiting (100%) [Table 7]. Significant improvement was found in Jarana Shakti (70.31%) [Table 9], Abhyavaharana Shakti (61.71%) [Table 8] and Mala Samata (83.02%) [Table 10].

Table 7

Effect of Shatapushpadya Churna (Group B) on complaints of Agnimandya (n=15)

Table 9

Effect of Shatapushpadya Churna (Group B) on Jarana Shakti (n=15)

Table 8

Effect of Shatapushpadya Churna (Group B) on Abhyavaharana Shakti (n=15)

Table 10

Effect of Shatapushpadya Churna (Group B) on Mala Samata (n=15)

Overall effect of therapy reveals that Group A had provided better effect than Group B [Tables 11, 12 and Figure 1].

Table 11

Overall effect of therapy of Group A and Group B

Table 12

Comparison of overall effect of therapy between Group A and Group B (n=15)

Figure 1

Comparison of effect of therapy between Group A and Group B on symptoms of Agnimandya

Probable mode of actionof lifestyle modification:

Agnimandya is a disease which involves impairment of digestive power. All the above mentioned causes are responsible for impairment of Ahara Parinamakara Bhavas and disruption of circadian rhythm of digestive enzymes. Modification in all these causes lead to re-establishment of Agni and improvement in status of Agnimandya.

Conclusion

Disturbance in lifestyle in the form of irregular sleep pattern and improper diet in take mainly affect the Ahara Parinamakara Bhavas and circadian rhythm which leads to manifestation of Agnimandya. In this clinical study, Group A (lifestyle modification), provided significantly better result (<0.005) in comparison to Group B (Shatapushpadya Churna). Thus, it can be concluded that lifestyle has major role in the manifestation and management of the Agnimandya.

Financial support and sponsorship

The study was supported by Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat.

Conflicts of interest

There are no conflicts of interest.

Table 1

Criteria for evaluation of lifestyle disturbance

Table 2

Criteria for assessment of effect of therapy