Title of the Research Project A clinical study
to evaluate the efficacy of tablet of Aloe
Vera gel (Aloe barbadenesis),Mur Makki (Commiphora myrrha) and Sanna-e-Makki
(Senna Alexandrina) in the management of
mild cases of confirmed Covid -19. Introduction Al-Qanoon Fit-Tib (Canon of
Medicine) one of the most famous ancient books of Unani System of Medicine has
discussed Pandemic diseases under the heading
"Wabaee Amraaz" (Pandemic diseases). The manifestations of a
particular pandemic disease discussed as
"Huma-e-Wabaee" (pandemic fever) is very much similar to
Covid-19. A complete description of cause, onset, spread, preventive aspects
and treatment of "Huma-e-Wabaee"
have been discussed in detail in this book. Two herbal medicine has been
suggested for prevention of pandemic disease in general and Huma-e-Wabaee in
particular in this book. These are Aloe Vera gel (Aloe barbadenesis),Mur Makki
(Commiphora myrrha). As per Hippocrates contaminated air with infective
material is one of the cause of pandemic diseases. It results in excessive
quantity of Phlegm (Lymph),Safra (yellow bile) and Sauda(black bile) in blood.
Sanna-e-Makki (Senna Alexandrina) is recommended to excrete these excessive
humors. These medicines are easily available and popular amongst masses. Hence a
clinical study to evaluate the efficacy of tablet of
Aloe Vera gel (Aloe barbadenesis),Mur Makki (Commiphora myrrha) and Sanna-e-Makki
(Senna Alexandrina) in the management of mild cases of confirmed Covid -19 would be carried out. Objectives Selection
of mild cases of confirmed Covid-19. Assessment
of fever by infra-red thermometer twice a day. Assessment
of SPO2 by pulse oximeter twice a day. Assessment
of Hemogram and Chest X Ray (PA view) before and after completion of study. IEC
Permission: Institutional Ethics Committee
permission will be taken before commencement of the project. Methodology
Materials
and Methods Materials Aloe Vera gel (Aloe barbadenesis), Mur
Makki (Commiphora myrrha) and Senna leaves (Senna alexandrina) will be
purchased from registered herbal / Unani pharmacy. Methods Mur
Makki (Commiphora myrrha), Aloe Vera gel (Aloe barbadenesis) and Senna Leaves (Senna
Alexandrina) will be taken in equal quantity by weight and tablet of 500 mg
will be made by registered Unani or herbal manufacturing unit. Sample size
60 patients. Inclusion criteria patients of mild cases of confirmed
Covid-19. Patients of both gender between the age group of 7 years to 60 yrs.
Patients having the following symptoms and signs will be included in the study. Fever above 1000
F Sore throat Dry cough Breathlessness Severe body ache SPO2
saturation above 92 Exclusion criteria Patients in whom
fever does not subside or increase in fever. SPO2 goes below 92. Increase in
Breathlessness. Immune-
compromised patients. Patient having co-morbidities. Duration of study 14
days. Dosage Two tablets twice for adults and one tablet
twice a day for children after meals
with water. Place of study
OPD of Z.V.M.Unani Medical College &
Hospital and Regional Research Institute of Unani Medicine,Byculla,Mumbai. Subjective parameters
Dry cough, breathlessness and body ache. Objective parameters
Fever, Pulse and SPO2
saturation. Investigations
Hemogram test before and after
completion of study. Statistical Analysis Data will be presented in the form of tables
and graphs by the use of MS-Excel and SPSS software version 20. Body
temperature,pulse,SPO2 ,dry cough, breathlessness and body ache)
would be analyzed using appropriate tests of significance. Probability (P) <
0.05 would be considered as significant. Result Result would be interpreted and discussed after
statistical analysis of data. Summary
and Conclusion Based on result of statistical analysis valid
conclusions will be drawn. Names of AYUSH Interventions/Medicines Aloe Vera gel (Aloe
barbadenesis) Mur Makki (Commiphora myrrha), and Senna Leaves (Senna
Alexandrina). Anticipated Outcome(s) Many clinical studies
in vitro and in vivo have been carried out to evaluate the antiviral activiy of Aloe Vera gel (Aloe
barbadenesis) , anti -inflammatory and analgesic activity of Mur Makki (Commiphora myrrha) and laxative
activity of Senna Leaves (Senna
Alexandrina). Hence it is expected that if these three medicine in combination
as a tablet will be effective if given
to the covid-19 confirmed cases having mild symptoms. Summary of the
proposed research (up to 150 words) indicating overall aims of the research,
importance of the objectives and their application in the context of the
priority area set out in the application form. Over
all aims of the research: To validate
efficacy of Aloe Vera gel (Aloe barbadenesis), Mur Makki
(Commiphora myrrha), and Senna Leaves (Senna Alexandrina) in the management of Covid-19.Positive outcome
of the study will provide acceptance of this system in scientific world and
will strengthen the faith of masses in AYUSH system of medicine. Importance
of the objectives Objectives
are based on subjective and objective parameters which are easy to assessed
even by the paramedic staff. Equipments
like infra red thermometer to note the temperature and pulse oximeter to
note Pulse and SPO2
saturation. These two equipments are easily available in every isolation center
of Covid-19. Rationale
of the study At
present, there are no specific vaccines or treatments are available for COVID-19. In India Ayurveda, Unani,
Siddha and Homeopathy are popular systems of medicine. People still have faith and prefer to use them. As they are effective,
practice based, evidence based, pocket
friendly and with minimal side effects. Hence it is high time to take
initiative to conduct pilot study to evaluate the efficacy of these medicine in mild cases of covid-19 patients. Relevance and usefulness of the study with
particular reference to concerned AYUSH system, in terms of -. IPR As Aloe
Vera gel (Aloe barbadenesis), Mur Makki (Commiphora myrrha), and Senna Leaves
(Senna Alexandrina) are mentioned for the management of
epidemic/pandemic diseases in classical literature of Unani System of Medicine,
hence the combination of these medicine in tablet form cannot be patented. Translational
Value: It can be used at
community level to mitigate the effects of Covid-19. In vitro and in
vivo studies on Sibr (Dried Aloe Vera gel)
can be carried out to evaluate the antiviral activity against Covid-19. Utilization of outcomes of project: Effective,
easily available and pocket friendly formulation will be available to masses. The
study will lessen the health care
and financial burden of the government.
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