Clinical evaluation of the efficacy of Dashanga Kwatha Ghana Vati in the management of Urdhwaga Amlapitta (Non-ulcer dyspepsia).

A study has been designed to evaluate the effectiveness of Dashanga Kwatha Ghana Vati in Urdhwaga Amlapitta (non-ulcer Dyspepsia). Randomized single blind, placebo controlled study was conducted in 138 patients attending O.P.D. of department of Basic Principles, I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar, and grouped into two. Both the groups consumed two tablets of either Dashanga Kwatha Ghana Vati or placebo, twice daily after food for a period of eight weeks. The patients were followed upto four weeks, 110 patients had completed the treatment and no adverse effects were reported during the treatment. Both groups had improved in the clinical symptoms and overall statistical significance was observed in the differences of scores between the two groups.

RCT Entities:   Population Interventions Outcomes

Introduction

From stone-age to space age food pattern of people has undergone innumerable changes. These changes have been always for the better aspect of life, yet most of the diseases are firmly rooted in poor dietary habits and life style.[1] None of the existing systems of medicines are providing satisfactory answers for all the health problems as all these aim at symptomatic relief rather than a total cure. Urdhwaga Amlapitta (non-ulcer dyspepsia) is a burning problem with causative factors like improper diet and habits, stress, spicy irritant foods, etc.

Acharya Charaka has mentioned that if a person is under psychological stress; even the wholesome food taken in proper quantity will not get properly digested.[2] Vagbhata has described that all diseases are caused due to Mandagni.[3] Among the Nidanas of Urdhwaga Amlapitta, dietary factors, addiction to alcohol, tobacco chewing or smoking, drinking tea several times are chiefly associated and commonly found.[4]

Even with the advent of excellent techniques and advancement in science and technology; the humanity is left with innumerable health problems. Most of the diseases have direct or indirect link with the type of food habits and life style. 80% of the top ten life threatening diseases of the world are due to faults in dietary habits.[5]

There are only a few safe and effective remedies available for the management of Urdhwaga Amlapitta. Although, in Ayurveda “Amlapittahara Dravyas” are described in general, but in practice, it is seen that all of them are not equally effective against the Urdhwaga Amlapitta. Clinical efficacy and safety of Dashanga Kwatha Ghana Vati is one of such remedies, which has not been evaluated till date.

Hence, an attempt has been made to evaluate the comparative efficacy and safety of Dashanga Kwatha Ghana Vati[6] with that of placebo in the management of Urdhwaga Amlapitta.

Materials and Methods

Study design and patient selection

This was a randomized single blind, placebo controlled trial. Patients attending O.P.D. of Department of Basic Principles, I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar, irrespective of sex, religion etc. who had presented the clinical symptoms of Urdhwaga Amlapitta were included into the study.

An elaborative case taking proforma was specially designed for the purpose of incorporating all aspects of the disease on Ayurvedic parlance. Informed consent was taken from the patient before including them in the trial.

Inclusion and exclusion criteria

Patients in between 15 to 65 years of age with classical signs and symptoms of Urdhwaga Amlapitta like Avipaka, Vidaha, Klama, Tiktamlodgara, Hritdaha, Kanthadaha, etc. were included in the trial. Patients who had chronicity for more than five years and suffering with diseases like gastric ulcer, duodenal ulcer, cancer of stomach and having major illness like cardiac diseases, diabetes, etc. were excluded from the trial.

Grouping

A total of 138 patients fulfilling the inclusion criteria were enrolled in the study. 110 patients completed study and 28 patients were discontinued. 82 patients were registered in Group A, among them 67 patients completed the treatment and 15 patients discontinued the treatment, whereas in Group B, total 56 patients were registered amongst them 43 patients completed the treatment and 13 patients discontinued.

Trial Group (Group A): 82 selected patients of Urdhwaga Amlapitta were placed in this group and were administered with Dashanga Kwatha Ghana Vati [Table 1] in the dose of 250 mg twice a day after food along with water as Anupana.

Table 1

Formulation composition of dashanga kwatha ghana vati

Placebo Group (Group B): In this group, 56 selected patients of Urdhwaga Amlapitta were administered with Placebo tablet prepared with gram flour in the dose of 250 mg twice a day after food along with water as Anupana.

Trial drug and posology

Duration of treatment: 8 weeks (56 days).

Diet: Patients were kept under normal diet with special restriction of Spicy diet.

Follow-up: The patients were followed-up once in seven days up to 28 days.

Laboratory Investigations:

Routine hematological investigations – Hb, TC, DC, E.S.R., P.C.V.

Urine examination – Routine and Microscopic.

Stool examination – Routine and Microscopic.

Biochemical examination – FBS, Sr. Cholesterol, Sr. Triglycerides, HDL, Blood Urea, Sr. Creatinine, S.G.P.T., S.G.O.T., Sr. Total Proteins, Albumin, Globulin, A/G Ratio, Sr. Alkaline Phosphate, Bilirubin (T), Bilirubin (D), Sr. Uric acid.

Above investigations were carried out before and after treatment to have a base line data, as well as to rule out any pathological conditions.

Criterion for assessment

The effect of the drug under trial was based mainly on the improvement in the cardinal signs and symptoms of the disease. To give some objectivity, the score was assigned as severe (3), moderate (2), mild (1), no symptom (0), to each of the major symptoms of the disease like Amlodgara, Daha, Shula, Chhardi and Avipaka. Similarly associated symptoms were also given scores, on the basis of before and after treatment score, the statistical analysis was done.

Statistical analysis

The obtained data was analyzed statistically and presented as mean ± SEM. The data generated during the study was subjected to student’s “Unpaired ‘t’ Test” for unpaired data to assess the statistical significance between the two groups. The change in signs and symptoms was analyzed by Paired’t’ test.

Observations and Results

Incidence of age and sex in 138 cases of Urdhwaga Amlapitta

There were 87 male and 51 female with a mean age of 37.98 years. Of which, 10.15% were belonging to an age group of 15-25 years, 33.33% to age group of 26-35 years, 35.5% to age group of 36-45 years, 17.4% of patients belonged to age group of 46-55 years, and 3.6% in 56-65 years of Age group.

Incidence of cardinal signs and symptoms in 138 cases of Urdhwaga Amlapitta

Amla Tikta Udgara and Hrit Kantha Daha was found in all (100%) registered patients, while Avipaka in 99.27% patients, Udara shoola in 91.30% patients and Chhardi was found in 68.11% patients [Table 2].

Table 2

Incidence of signs and symptoms in 138 cases of Urdhwaga Amlapitta

The incidence of associated signs and symptoms in 138 cases of Urdhwaga Amlapitta

Aruchi was found in all the registered patients (100%), while Hrillasa in 95.65%, Gaurava in 90.57%, Agnimandya in 80.43%, Vibandha in 78.26% and Shira Shoola in 74.63% of patients [Table 3].

Table 3

Incidence of associated signs and symptoms in 138 cases of Urdhwaga Amlapitta

Percentage-wise improvement in signs and symptoms of Urdhwaga Amlapitta in both groups

Maximum decrease in Amla Tikta Udgara after treatment was seen in Group A with 76.59% than Group B with 44.85%. Maximum decrease in Hrit Kantha Daha after treatment was seen in Group A with 81.62% than Group B with 48%. Maximum decrease in Udara Shoola after treatment was seen in Group A with 81.34% than Group B with 41.46%. Maximum decrease in Avipaka after treatment was seen in Group A with 91.13% than Group B with 50%. Maximum decrease in Chhardi after treatment was seen in Group A with 97.22% than Group B with 78.37%.

Comparative results of improvement in signs and symptoms of Urdhwaga Amlapitta in both groups

Statistically significant results of improvement in signs and symptoms of Urdhwaga Amlapitta were observed in Group A when compared with Group B [Table 4].

Table 4

Effect of therapy on hematological and bio chemical measures

Effect on hematological and bio chemical measures

No significant difference was observed in the mean change of hematological and bio chemical parameters after the drug administration [Table 5].

Table 5

Effect of therapy on cardinal and associated signs and symptoms

Overall effect of therapy

In group A, complete remission was observed in 2.44% of patients, while in group B complete remission was not found. Marked improvement was found in 59.7% in Group A, while in Group B 1.8%. Moderate improvement observed in Group A was 18.3% and in Group B it was 32.1%. Mild improvement observed in Group A was 1.22% and in Group B it was 39.3%.Only two patients (3.57%) in Group B were found to be unchanged [Table 6].

Table 6

Overall effect of therapy

Adverse drug effects

Administration of trial drug did not associated with any clinically important adverse effects on blood pressure, pulse rate, body weight or laboratory assays.

Disucssion

The present study aimed to look for an effective, safe and affordable treatment of Urdhwaga Amlapitta. However, the herbal combination Dashanga Kwatha Ghana Vati used in this study showed better improvement in symptoms when compared to placebo. This trial drug was found to be well tolerated with no adverse effects.

Most of the etiological factors of Urdhwaga Amlapitta are related with the diet and life style. If one does not follow proper dietic habits, Agni will be diminished due to irregularities in the digestion and finally will lead to Urdhwaga Amlapitta. Maximum number of patients belonged to the age group between 26 to 45 years i.e. 68.83%. It is the most productive age in one’s own life, since they struggle for upcoming in their economic status by which they suffer from stress and strain. Irregular food and drinking habits might have led to more incidences. This age is also of Pitta dominance.

Most of the individuals (99.3%) were taking Katu Rasa dominant food, followed by Amla (90.6%), and Lavana (53.6%). This observation proves the classical etiological factors in causing and aggravating the disease. 21.72% patients had a habit of Adhyashana. Charaka has advised to take food only after digestion of the previous meal. Adhyashana cause aggravation of Doshas and due to insufficient rest to the stomach the mucous membrane may undergo local damage. 43.47% patients were addicted to chewing tobacco which due to its Ushna, Tikshna, Vyavayi Gunas aggravate the Amlapitta. 28.26% patients were having Krura Koshtha which is due to Vata Dosha. These people were more prone to constipation which is also one of the symptoms of Urdhwaga Amlapitta. Stress is a known factor for disturbing the sleep. In this study more patients reported disturbed sleep followed by Alpanidra.

These beneficial actions of Dashanga Kwatha Ghana Vati might be due to the synergistic action of its ingredients, which possesses activities like anti-bacterial,[7] anti-inflammatory,[8] anti-spasmodic,[9] anti-ulcer[10] etc.

Probable mode of action of Dashanga Kwatha Ghana Vati

The chief Dosha involved in the Urdhwaga Amlapita is Pitta and Kapha.[11] Majority of the drugs of this formulation have Tikta and Kashaya Rasa, Katu and Madhura Vipaka, Sheeta Virya, Pitta Kapha Shamaka property. In Urdhwaga Amlapitta, Rasa Dhatu is affected. The property of Deepana and Pachana Karma and Tikta Rasa of the drugs will directly act on the vitiated Rasa Dhatu. Due to Tikta Rasa property, Sama Pitta will become Nirama and Agni will be increased. Charaka says that Manadagni and Ajirna creates Annavisha, when it gets mixed with Pitta Dosha, creates Pittaja Vyadhis[12] like Amlapitta. So, the Tikta Rasa property of the drugs purifies the Pitta by Niramikarana. Acharyas have also given the treatment of Pittaja disorders and says that first of all Tikta Rasa Dravyas have to be used for Niramikarana of Pitta and then after Madhura Rasa and Kashaya Rasa should be used to pacify Paittika Vyadhis.

Conclusion

Dashanga Kwatha Ghana Vati has shown significant relief in Urdhwaga Amlapitta in comparison to the placebo group. Encouraging results were also observed in the placebo group, which may be because of certain dietary restrictions advised to the enrolled patients during trial period. No clinically significant changes were observed in hematological or biochemical parameters after the study. No adverse drug reactions were noted with administration of the trial drug for 8 weeks of duration. Based on the results of the current study, it can be concluded that the trial drug can be used in cases of Urdhwaga Amlapitta (Non ulcer dyspepsia).