THE
TEST EFFICACY OF HOMOEOPATHIC PROPHYLAXIS ARSENICUM ALBUM
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.
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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