Efficacy of Shunti and Badara Churna in Motion Sickness: A Single Blind,Placebo Controlled Clinical Trial

Introduction

Ayurveda is a traditional system of Indian medicine that is still being practiced successfully. Review and adaptation of the ancient science to contemporary drug discovery processes can bring renewed interest to the pharmaceutical world and offer unique therapeutic solutions for a wide range of human disorders. Acharyas have explained immense treasure in the form of their selfwritten texts called Samhitas. These Samhitas behold within them great knowledge and information about the etiology, pathology, clinical features and management of various diseases. This information is based on the observations and experimentations conducted by ancient seers at various levels. Hence one cannot easily deny the observations put forward by the Acharyas, and it becomes Aptopadesha in the context of Ayurveda.

By virtue of health benefits, medicinal values, natural origin and less side effects, herbal medicine has seen exponential growth in last few decades, in both developed and developing countries. There are large number of traditional medicinal uses that are not necessarily based on knowledge of the constituents. Vomiting/chardi is the most distressing symptom of motion sickness (MS). Treating motion sickness focuses on easing nausea and vomiting. Ayurveda has many drugs that have chardihara property. Badara (Zizhyphus jujuba) is one among chardi nigrahana gana dravya of charaka samhita. It is indicated in Kaiyadeva nighantu for chardi.¹ Shunti (Zinziber officinalis) is mentioned as vamihara in Bhavapraka nighantu.² As both the drugs were easily available and abundant, they were considered for the study. Therefore, this study was undertaken to observe the role of these drugs in MS. The present study is a step towards developing a remedy in the management of MS. Here an effort has been made to explain the efficacy of Shunti and Badara in the motion sickness thorugh a clinical study.

Description of motion sickness

MS is a natural autonomic response to an unfamiliar or specific stimulus. The human body responds to unfamiliar or specific stimulus as motion sickness. MS response is highly individual and contextually dependent, leading to difficulty in predicting vulnerable people. The initial autonomic responses are similar to the ones demonstrated when under stress. An estimated 33% people are prone to motion sickness even in very mild circumstances and 66% people are vulnerable in severe circumstances like travelling by car or a ship etc. The people prone to or suffering from MS will experience low motivation and ability to perform the tasks and duties. However, little is known about how specific cognitive functions are affected. The current strategies of treating MS involves medications that induce fatigue or strategies that require cognitive capabilities. Both of them can lead to reduced capability to perform assigned tasks or duties. Hence, alternative mitigation strategies³ find relevance.

Materials and Methods

Patient selection

The study was a single blind, placebo control, comparative clinical trial. The study protocol was approved by the institutional ethics committee. Forty-five patients fulfilling the diagnostic criteria of motion sickness with respect to age, sex and irrespective of caste, religion & socio-economic status approaching the OPD & IPD of Government Ayurveda Medical College and Hospital, Mysore were selected for the study. They were assigned into three groups for the interventional study. Rotation chair was designed by expertise. Also, a detailed clinical case proforma was specially designed for the purpose of recording all the aspects of disease from modern medical science as well on Ayurvedic parlance.

Study design with grouping and posology

It was a comparative clinical study. Forty-five patients with motion sickness were incidentally selected by random method and were divided into three groups by lottery method. i.e,

Group A - 15 patients administered with Shunti 1 g

Group B - 15 patients administered with Badara 10 g

Group C - 15 patients administered with Placebo 10 g

Participants gave written informed consent prior to inclusion, and complete disclosure of the study purpose was offered to all the participants before the study procedure.

Specially designed rotation chair

Rotation Procedure:⁴ Instructions were given to the participant before starting the rotation procedure.

1. The rotation of the chair was done for 5 min at a constant speed of 120 degrees/sec (20 rounds per min)

2. A beep alarm was given every 10 sec. During the rotations, the participant was instructed to move his/ her head up and down when he/she heard the beep tone.

3. Participant should not vomit during the procedure and can skip head movements or tell the experimenter to stop the rotation in time. However, the runs can be interrupted immediately, or the entire procedure can be stopped if necessary.

4. After the rotation procedure, the participants were asked to rate the Simulator Sickness Questionnaire (SSQ).⁵

Diagnostic criteria

According to ICD 10, the criteria adopted were:

 Cold sweats

 Dizziness

 Nausea

 Vomiting

Patients exhibiting all or any of the above symptoms were considered for the study.

Inclusion criteria

Patients of either sex in the age group of 18-60 years.

Patients with symptoms of motion sickness.

Patients willing to participate in the study.

Exclusion criteria

Patients suffering from other systemic illnesses and on any other medications. Pregnancy and lactating women. Patients suffering from ocular or vestibular disorders. Patients who underwent surgery of gastro-intestinal system.

Assessment criteria

Objective parameters were assessed before and after the intervention by simulator sickness questionnaire (SSQ).5 Written informed consent was obtained prior to inclusion, and complete disclosure of the study purpose was offered to all the participants before the study procedure.

Statistical analysis

The results of the present study were analyzed statistically using descriptive statistics, chi-square test, and contingency table analysis using SPSS for windows software.

Results

A maximum number of study subjects i.e. 30 (66.7%) patients were below 20 years of age, 9 (20%) patients were 21 – 30 years of age, 4 (8.9%) patients were 31 – 40 years of age, 2 (4.4%) patients were above 40 years of age. This showed the high incidence in younger age groups. As evident, MS starts manifesting early and decreases as the age progresses.

Generally speaking, females were more susceptible to motion sickness than males. In the present study, 11 (24.4%) patients were males and 34 (75.6%) patients were females, which indicates that females were more susceptible than males. Figure 1 shows the time duration of susceptibility in rotation chair before and after treatment. Figure 2 show the comparative efficacy of the treatment.

Discussion

The present study was conducted to evaluate the efficacy of shunti and badara churna on motion sickness. Vomiting/chardi is the most distressing symptom of MS. Treating motion sickness focuses on easing nausea and vomiting. Ayurveda has many drugs that have chardi hara property.

Badara (Zizhyphus jujuba) is one among chardinigrahana gana dravya of Charaka Samhita. It is indicated in Kaiyadeva nighantu for chardi.

Shunti (Zinziber officinalis) is mentioned as vami hara in Bhavapraka nighantu. As both the drugs were easily available and abundant, they were considered for the study

Dosage: Aushadha kalpana selected for the study was choorna kalpana as these drugs are more often used in churna form. Dose was decided as per the reference in classical texts. Hence they were used in the similar fashion i.e Shunti–1 g, Badara – 10 g were administered orally during the pre and post test of rotation chair study paradigm.

Selection of Rotation chair model: There are many models to induce motion sickness such as exposure to virtual environment, travelling in ghat section, rotation chair etc. Among them, rotation chair was used to induce or simulate the symptoms of MS in the study subjects as it was reliable, feasible, cost effective, and an easy method to evaluate the symptoms of motion sickness by appropriate objective parameters rather than depending on the subjective parameters.

Procedure of simulation: The rotation procedure consisted of 5 min of rotation at a constant speed of 120 degrees/sec (20 rounds per min), which contained adjustable regulator according to weight of the study subjects. During rotations, the participant hears a beep every 10 sec. The participants were instructed to move head up and down when beep tone was heard. They were instructed to do so to induce the “Coriolis effect” (the experience of an illusionary tumbling movement that leads to symptoms of nausea).

The instruments like BP apparatus and pulse oximeter were utilized in the study to check the BP, pulse rate and oxygen saturation in the study subjects.

In the present study, the severity of motion sickness was assessed using the Simulator Sickness Questionnaire. The SSQ was designed by the author to assess the severity of a variety of symptoms that are often associated with motion sickness, such as fatigue, eyestrain, vertigo and nausea. It was not designed to indicate, on a yes/no basis, whether any individual was or was not motion sick (R. S. Kennedy, personal communication, September 2007). The SSQ was administered at the pre and post test of present study which was suitable for this study set up. The improvement of patients was assessed on the basis of relief in the signs and symptoms of MS. To analyze the efficacy of the drug, scoring was given statistically to each symptom. According to severity of the symptoms, the grading was given as 0, 1, 2, 3 for none, mild, moderate and severe respectively.

The present study contained three study groups:

1. Group A (intervention with ginger)

2. Group B (intervention with jujuba)

3. Group C (placebo group)

The analysis with statistical tests revealed significant reduction in symptoms with p value fatigue (.013), eyestrain (.015), dizziness with eye open (.044), vertigo (.000), stomach awareness (.007) in ginger group. The reduction in symptoms of MS in placebo and jujuba group were not statistically significant.

Mode of action: The most critical of motion sickness comes from vestibular system which goes to the vestibular nuclei and from nuclei to the vomiting center, leading to nausea and vomiting, the cardinal features of motion sickness (Yates et al 1998).

A number of neurotransmitters and neuromodulator have been shown to influence the activity of vestibular nucleus neurons, such as acetyl choline, glutamate, GABA, histamine, nor- epinephrine, dopamine, serotonin etc.

The reduction in symptoms of ginger group may be possibly attributed to the anti-emetic activity of ginger. In comparison with group B the jujuba group, ginger group fared better with significant results in certain symptoms. This shows that among the two drugs, ginger is better or was able to reduce the symptoms of MS indicating its activity on MS.

It can also be said that the reduction which was significant in ginger group is solely because of the properties of ginger and not due to the placebo effect, as the placebo group which was considered as a control has not showed any significant reduction in symptoms.

Conclusion

Rotation chair could be used as a tool to simulate motion sickness. The clinical study showed significant results in the ginger group when compared with the other two groups. Study has shown significant reduction in symptoms with p value fatigue (0.013), eyestrain (0.015), dizziness with eye open (0.044), vertigo (0.000), stomach awareness (0.007) in ginger group. It can also be said that the reduction which was significant in ginger group is solely because of the properties of ginger and not due to the placebo effect, as the placebo group which was considered as a control has not showed any significant reduction in symptoms.

Hence with this study, it could be concluded that ginger has a positive effect on reduction of symptoms such as fatigue, eye strain, dizziness with eye open, vertigo and stomach awareness of MS. Due to its madhura vipaka, it can be taken as klama hara, paachana, amavataghni, vata hara. Hence shunti is a worthy choice of drug in treating motion sickness.

Conflicts of Interest

Declared.