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CTRI Number  CTRI/2020/07/026669 [Registered on: 18/07/2020] Trial Registered Prospectively
Last Modified On: 18/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Preventive 
Study Design  Single Arm Trial 
Public Title of Study   Unani Herbal tablets for mild cases od Covid 19 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ghazala Mulla 
Designation  Head of Department Physiology 
Affiliation  ZVM Unani Medical College and Hospital 
Address  Department of Physiology Room Number 1 Division Nil First Floor Z V M Unani Medical College and Hospital
Azam Campus Camp Pune K B Hidaytullah Road
Pune
MAHARASHTRA
411001
India 
Phone  09922410312  
Fax    
Email  ghazalamulla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jalis Ahmed 
Designation  Principal 
Affiliation  Z V M Unani Medical College and Hospital 
Address  Dept of Siadla Ground Floor Room No 1 Division Nil Z V M Unani Medical College and Hospital
Azam Campus Camp Pune K B Hidaytullah Road
Pune
MAHARASHTRA
411001
India 
Phone  09850541686  
Fax    
Email  jalishmd@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shaikh Nikhat 
Designation  Research officer  
Affiliation  Regional Research Institute of Unani Medicine Mumbai 
Address  Ground Floor Room No 2 Division Nil Regional Research Institute of Unani Medicine
Gate No 9 J J Hospital Compound Byculla Mumbai
Mumbai
MAHARASHTRA
400008
India 
Phone  9820399433  
Fax    
Email  drnikhat.unani@gmail.com  
 
Source of Monetary or Material Support  
Z V M Unani Medical College and Hospital Azam Campus Camp Pune 411001 K B Hidaytulla Road  
 
Primary Sponsor  
Name  Z V M Unani Medical College  
Address  Z V M Unani Medical College and Hospital Azam Campus Camp Pune 411001 
Type of Sponsor  Other [Govt aided Medical College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharmeen  Covid Care Center  Covid Care Center Kausa stedium room no 1 to 7 Division Nil Thane Muncipal Corporation Mumbra 400612
Mumbai (Suburban)
MAHARASHTRA 
9082190522

sharminnakhwa.sd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of M C E Society  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Unani Herbal Formulation in tablet form  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. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients of mild cases of confirmed Covid-19.
Fever above 1000 F
Sore throat
Dry cough
Breathlessness
Severe body ache
SPO2 saturation above 92

 
 
ExclusionCriteria 
Details  Patients in whom fever does not subside or increase in fever, SPO2 goes below 92.Increase in Breathlessness, then such patients will be excluded from the study.
Immune- compromised patients. Patient having Ischemic heart disease
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Oxygen saturation of patients and decrease in temperature  SPO2 and temperature will be assessed daily twice from 0 day to 14 day  
 
Secondary Outcome  
Outcome  TimePoints 
Pocket friendly effective medicine will be available  14 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

                                     

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.

SPOgoes 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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