SRM institute of science and technology under flagship of Unnat Bharat Abhiyan conducted the test efficacy of Homoeopathic prophylaxis Arsenicum album at 30 C, 200 C potencies with placebo-controlled Randomized Clinical Trial. This study also tries to empathize with the role of Homoeopathic in Pandemics.

The inauguration was held at SRM University Kattankulathur campus from 4.12.2020 to 9.12.2020. Eligible field investigators are appointed and were invited to receive training within this timeframe. The Unnat Bharat Abhiyan nodal officer Dr.V.Thirumurugan was acquainted with field workers, the introduction of the study process, the need and importance of this particular study, and all the precautionary methods were explained in detail in their native language (Tamil) and English for better understanding. DrPadmavathyVenkatsubramanian, Dean School of public health and Principle investigator of this project, gave a brief introduction about AYUSH systems, the benefit of choosing AYUSH medicine cost-effective well as highly needed to control this pandemic.

      Dr Alex Joseph, a Homoeopathic physician, and epidemiologist, the principal investigator of this study, explained the clinical trial process, which was the first to happen in Tamil Nadu, awareness about homeopathic medicine wide range practice across the globe. The usage and perception of Homoeopathy in the Indian population. The preparation, sphere of action of the medication, holistic approach, limited side effects, and mode of administration. The principal investigator also shared the results and outcomes of previous studies. The principal investigator also gave enough information about the trial processing, choice of villages, especially those that were under Unnat Bharat Abhiyan, benefits for the engagement of the field investigator from the UBA villages by creating employment opportunities by contributing their works to this study, blinding procedures, quadruple blinding which was the strength of this study by this way all the participants, field investigators, trial coordinators, and outcome assessors remain blinded to the drugs allocated to the clusters, the principal investigators summarized all this information. The safety procedures like maintaining social distancing, hand hygiene, wearing masks, and supplying necessary PPE kits were instructed and strictly followed by the field investigators. The details of the health insurance for the field investigators in case of any adverse events during the study will be monitored. Instruction about the selection criteria of the study participants with their proper concern was delivered



       DrR.Yogalakshmi, Homoeopathic Physician, explained about homoeopathic systems so that the field investigator tastes the essence of the homoeopathic way of treatment, its approach, the art of healing, cost-effectiveness, and they educate the study participants for the same. In this way, the field investigator can tackle the situation and educate the participants about all the questions regarding homoeopathy. The administration of drugs, the number of days, and the repetition of doses at intervals were discussed. The side effects of homoeopathic medicine, particularly the preparation of medication, drug intake, and allopathy, and other traditional medicine, were explained. The field investigators' doubts and questions regarding general awareness about homoeopathy and how they can educate the study participants with knowledge of homoeopathic systems, proper intake of medicine were answered. The field investigators were trained to make them aware and equipped themselves to cope with the situation. If the study participants had any doubt regarding homoeopathy medication, any adverse events, emergencies, and contacting the respective authorities were provided.

The Trial Coordinators, MrBala Ganesh, specialization in public health, and MrSiranjeevi, explained the way of approaching the participants, introduction about each segment of the questionnaire such as basic demographic details of the study participants, identification/sample numbering, assessing  General health status of the participants, information regarding COVID- 19 disease was delivered on the first day / during the inauguration.

In continuation to the first day of the training session with the introduction part of the questionnaire, the trial coordinators continued to train the field investigators for six days. Since the survey was planned to be done using electronic devices like mobile phones or tablets for data collection, field investigators were ensured to carry all their gadgets fully charged. A questionnaire was an ODK form; hence the details about the software KOBOCOLLECT were introduced. Kobo collect was a user-friendly software, and the questionnaire form was made easily accessible by clicking the link and opening it in any convenient browsers. The ODK form was made usable even without an internet connection. It was uploaded whenever the internet connection is retained, so there will be no interruption during data collection while using this ODK questionnaire. The questionnaire was designed for both languages, English and Tamil, for better understanding. Initially, presentations of the questionnaire were done by trial coordinators in their regional language for improved communication and to clarify doubts.

          Instructions about the first segment, the investigation code, medicine code, household number, sample number, caste, education, and qualification were instructed to enter an orderly fashion. The continuation of the sample number each day was followed carefully according to the guidelines that get updated daily during the trial period. Field investigators will also be trained on how to approach each participant, entering the household, getting concerned about their interest to take part in the study, explaining the need and aim of the current trial, knowledge about their contributions to the study, and any concern after taking medication, adverse health effects, trained to respond politely.

Followed by the introduction segment, the next segment of the questionnaire was to assess the general health status of the subject. Since this set of questions has some medical conditions like Blood pressure, tuberculosis, Cataract, Asthma, cancer, Parkinson’s disease, etc., training for the pronunciation, meaning, how they can ask this question, list of treatment and medications was instructed to enter properly.

Information regarding the COVID-19 disease assessment questionnaire was the most crucial segment determining whether the individual is infected with COVID-19 and the exposure status towards COVID-19--19. Field investigators were instructed to explain every question in this segment and ask the possible answers they tend to get during the survey. Field investigators were practiced to ask all the questions clearly and organized to complete within the time.

After the oral presentation and explaining all the questions by trail coordinators and research team members, the field investigators were asked to present individually. This allowed them to practice, and any questions they had about the questions were answered. They also practised the possible way of asking the questions so that they became more familiar. The doubts and clarification in the questionnaire were cleared and get updated simultaneously. They were also instructed to reach the Trial coordinator for any help or clarifications during the survey. They were also trained to practice these questions using ODK form using their mobile phones. The research team resolved problems like buffering, updating answers, and sorting and rectifying other challenges simultaneously. Practical sessions like group discussion, where 4-5 members gathered and practised asking each other questions.

Guidelines about the precautionary measures while conducting the household survey were asked to follow without fail. Proper usage of PPE (Personal protective equipment), wearing a mask while talking to the participant, practising hand hygiene frequently on a touch of any infected objects, coughing and sneezing within the elbow, washing hands for 20 minutes after coughing, maintain social distancing during the survey and asked to spread the same awareness to the participants, wearing gloves, proper disposal of PPE, gloves, and mask, all these protocols were instructed to follow strictly in the field. During the survey, any health changes or illness for the field investigators were asked to immediately report to the trial coordinators.

At the end of this training session, mock training was conducted at one of the villages chosen for this study. Field investigators were taken to Thenmelpakkam village and asked to undergo a trial process using this questionnaire.  Trial-coordinators accompany them, and they were monitored while practising the questionnaire, and the practical aspect of approaching the participants was trained. After discussion with the research team members, principal investigators, field investigators, and trial coordinators, the randomized controlled trial was executed as planned.

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