“A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHIwww.pijar.org MANTHA IN MOTION SICKNESS” ISSN:2456:4354 Research Article “A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHI MANTHA IN MOTION SICKNESS” Ajit. N. B1, V.A. Chate2, Shreevathsa3, Suma patil4 1&4PG Scholar,2Reader,3Professor and Head department of Samhita and Siddhanta, GAMC,Mysuru. Abstract Motion sickness is common problem faced by most people while travelling by bus, car, train, airplaine and boats. It starts with restlessness and later leads to dizziness, nausea and vomiting. It has synonyms like air Sickness, Car Sickness, Sea Sickness, Travel Sickness and Vomiting. To treat motion sickness mainly antihistamines like scopolamine, promethazine etc drugs are used. In long term usage of these drugs, it produces extra pyramidal signs so it is necessary that, to treat motion sickness without producing un toward effect and to give strength to the patient such one medicine in Masuradhi mantha. Masuradhi is the prepartion made up of masurdal, Madhu and Dadima phala rasa. So in the present article clinical study is conducted in the 80 individuals with motion sickness symptoms. Key words Motion sickness, Masuradhdi mantha, Simulator sickness, questionnaire nausea INTRODUCTION: vehicles. During travelling in bus, car In this fast moving world, everyone is or boat some get travelling sickness or busy in making their life to move fast motion sickness. Motion sickness is forward. Everyone is travelling one not a serious illness, but one place to another to fulfil their desires, habituates to such environment to work, and to achieve. Most of the regularly it will become a serious persons choose buses, cars and other illness. PIJAR/July-August-17/volume 1/Isue-6 Page 138 “A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHI MANTHA IN MOTION SICKNESS” It produces symptoms like, fulfilling the diagnostic criteria, Nausea, respective of age, irrespective sex, Vomiting, religion and socioeconomic status were Dizziness and selected. To create motion sickness cold sweat. mechanically, rotation chair was Anti- histamine drugs like scopolamine, prepared. promethazine etc. drugs are used. But Inclusion criteria these anti histamines produce side Individuals fulfilling the diagnostic effects like drowsiness, extra criteria for the respective disease. pyramidal signs1. It is better to use The patients coming under the age food rather than using medicine for group of 18-60 years were selected. the treatment of motion sickness, The healthy volunteers willing to take because food acts as both vyadhi hara the medicine were selected for the and swastya sthapaka. Masuradhi study. mantha is a preparation, which is used Exclusion Criteria: in tridoshajanya chardi2. In motion Patients suffering from head injuries, sickness, vomiting is the prime recent infections and other diseases of symptom; hence in the present article the ear and neurological system are a randomised clinical trial is done on excluded. 80 individuals with motion sickness Pregnant and lactating women are symptoms. excluded and Aims and objectives Patients suffering from other systemic To evaluate the effect of Mauradhi diseases are excluded. mantha in motion sickness. Protocol Materials and Methods The study protocol was approved by A minimum of 80 individuals fulfilling the ethical committee of GAMC inclusion criteria approaching the Mysore. Participants gave written inpatient and outpatient department of informed consent prior to inclusion, Government Ayurveda medical college and complete disclosure of the study and hospital Mysore and the special purpose was offered to all participants camps conducted in and around the before the study procedure. Mysore were selected and patients Rotation Procedure: PIJAR/July-August-17/volume 1/Isue-6 Page 139 “A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHI MANTHA IN MOTION SICKNESS” Instructions to the participant before Patients exhibiting all or any of the starting the rotation procedure. above symptoms are to be considered 1. The rotation procedure consists of 5 for the study. min of rotation at a constant speed of Assessment criteria: 120 degrees/sec (20 rounds per min). The pre and post test assessment of 2. The participant hear a beep every motion sickness will be done by using 10 sec. During rotations, the “Simulator Sickness Questionnaire” participant was instructed to move (SSQ). his/her head up and down when Grouping of Patients he/she heard the beep tone. The study design will be randomised 3. Participants should not vomit during clinical trial with a pre and post test the procedure and can skip head assessment. Patients were categorized movements or tell the experimenter to into single group. stop the rotation in time. Statistical Methods: However, the runs can be interrupted 1. Descriptive statistics. immediately, or the entire procedure 2. Chi square test, can be stopped if necessary. 3. Contingency table analysis and 3. During the rotation procedure, note 4. Repeated measure ANOVA by using the actually done head movements windows SPSS soft ware. and the rotation time. Observations and Results 4. After rotation procedure the Specific observations made on 80 participants were asked to rate the subjects are, Simulator Sickness Questionnaire a .Nausea (SSQ). In the present study 50(62.5%) were Diagnostic Criteria: presents with nausea and 30(37.5%) As per ICD 10 symptoms of were not had the nausea. motion sickness are b. Vomiting cold sweat In the study 54(67.5%) were not felt Nausea with vomiting and 26(32.5%) had Vomiting suffered from vomiting. Dizziness c. Dizziness PIJAR/July-August-17/volume 1/Isue-6 Page 140 “A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHI MANTHA IN MOTION SICKNESS” In the study 67(83.8%) were not had e. Head Ache the symptom and 13(16.3%) were had In the study 45(56.3%) not felt with the symptoms. headache and 35(43.8%) felt with d. Cold Sweat headache. In the study, 73(91.3%) not had the symptom and 7(8.8%) had this symptom. Graph no. 1 showing the classical symptoms of motion sickness observed in travelling. Nausea Vomiting Dizziness Cold sweat Results Results obtained from clinical study are, Table no 1 showing the para meters of the motion sickness and its p value. Sl Motion Sickness P value .no Parameters 1 General discomfort .001. 2 Fatigue 0.672 3 Headache 0.648 4 Eye Strain 0.220 5 Difficulty In Focusing 0.024 6 Salivation increasing 0.398 PIJAR/July-August-17/volume 1/Isue-6 Page 141 “A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHI MANTHA IN MOTION SICKNESS” 7 Sweating 0.082 8 Nausea 0.114 9 Difficulty concentrating 0.797 10 Fullness of head 0.741 11 Blurred vision 0.06 12 Dizziness with eyes open 0.009 13 Dizziness with eyes 0.07 closed 14 Vertigo 0.05 15 Stomach awareness 0.659 16 Burping 0.076 From the above results it states that, Masuradhi mantha is showed statistically significant results in controlling, general discomfort (0.001), difficulty in focusing (0.024), and difficulty with eyes open (0.009), vertigo (0.05) and burping (0.076). Graph no.2 showing effect of Masuradhi mantha on general discomfort, dizziness with eyes open, difficulty focusing and vertigo. General discomfort Dizziness with eyes open Difficulty focusing Vertigo PIJAR/July-August-17/volume 1/Isue-6 Page 142 “A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHI MANTHA IN MOTION SICKNESS” Discussion; and oxygen saturation in the study Discussion on methods: patients. 1. Rotation chair: Rotation chair was Discussion on inclusion criteria used to induce or simulate the Individuals full filling the diagnostic symptoms of motion sickness in the criteria were selected for the study, study subjects. individuals who come under the age Procedure of simulation -The rotation group between 18- 60 were selected procedure consists of 5 min of rotation because motion sickness is common in at a constant speed of 120 this age group and also individuals degrees/sec (20 rounds per min). who wishes to take medicine During rotations, the participant hears voluntarily with the motion sickness a beep at every 10 second. The symptoms was to be selected for the participants were instructed to move study. head up and down when beep tone Discussion on Exclusion criteria was heard. They were instructed to do Patients with any other systemic so, to induce the “Coriolis effect” (the disorders, head injuries &recent experience of an illusionary tumbling infections are excluded interference in movement that leads to symptoms of the action of the drug and also to nausea). avoid complications. The presence of 2. The instruments like BP apparatus and these conditions could possibly trigger pulse oxymeter was used in the study or aggravate Motion sickness like to check the blood pressure, pulse rate symptoms when simulated by the PIJAR/July-August-17/volume 1/Isue-6 Page 143 “A RANDOMISED CLINICAL TRIAL TO EVALUATE EFFECT OF MASURADHI MANTHA IN MOTION SICKNESS” rotation and also would aggravate the difficultly focusing, fullness of head symptoms. and blurred vision. These items are Discussion on Simulator Sickness considered under occulomotor items Questionnaire(SSQ) because from disturbance between Simulator sickness Questionnaire audio- visual sensory organs these are (SSQ) is used as reliable assessment taken. measures for the effect of treatment. With the permission and supply of the Discussion on results of the questionnaire from Kennedy, R.S., clinical study Lane, N.E., Berbaum, K.S., & Lilienthal, Among 80 individuals, 16 symptoms M.G. (1993). were asked for assessment of motion Simulator Sickness Questionnaire is an sickness. Among the 16 symptoms, enhanced method for quantifying Masuradhi mantha showed statistical simulator sickness taken from significant results for, International Journal of Aviation General discomfort: Due to laghu Psychology, 3(3). The guna of mantha, sadyobalakara Questionnaireconsisted of 16 property it is reduced the symptom parameters on two domains namely, general discomfort significantly.