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CTRI Number  CTRI/2023/08/056975 [Registered on: 28/08/2023] Trial Registered Prospectively
Last Modified On: 29/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study To Evaluate the efficacy of polyherbal Unani formulation in Zukam (Coryza OR Common Cold) 
Scientific Title of Study   "TO EVALUATE THE EFFICACY AND SAFETY OF POLYHERBAL UNANI FORMULATIONS IN ZUKAM (CORYZA OR THE COMMON COLDE A RANDOMIZED STANDARD CONTROLLED CLINICAL TRIAL)" 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Moh Jishan Gazi 
Designation  PG SCHOLAR 
Affiliation  State Unani Medical College 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone  7830967733  
Fax    
Email  mohdzeeshannoor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mohd Asif Hussain Usmani 
Designation  Professor and Head of the department 
Affiliation  State Unani medical College Prayagraj 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India Allahabad UTTAR PRADESH 211016 India

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905831926  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Usamah Ahmad 
Designation  Associate Professor 
Affiliation  State Unani Medical College Prayagraj 
Address  Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani Medical College, himmatganj Prayagraj 211016 India Allahabad UTTAR PRADESH 211016 India Allahabad UTTAR PRADESH 211016

Allahabad
UTTAR PRADESH
211016
India 
Phone  9415639877  
Fax    
Email  Arogyaherbal@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College, himmatganj Prayagraj- 211016 
 
Primary Sponsor  
Name  State Unani Medical College  
Address  IPD/OPD of Department of Amraze Ain Uzn Anf Halaq wa Asnan State Unani Medical College, himmatganj Prayagraj 211016 India  
Type of Sponsor  Research institution and hospital 
 
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 
Moh Jishan Gazi  OPD/IPD of Ain, Uzn, Anf, Halaq wa Asnan   State Unani Medical College & HAHRDM Hospital Prayagraj 211016 Allahabad UTTAR PRADESH Allahabad UTTAR PRADESH
Allahabad
UTTAR PRADESH 		 7830967733

mohdzeeshanoor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J349||Unspecified disorder of nose and nasal sinuses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Joshandha(Decoction) of bahidana unnab and Sapistan With Sharbate Banafsha 24ml for 7 days  Joshandha(Decoction) of Bahidana(Cydonia oblongata) 3gm, Unnab Zizyphus vulgaris 5no.(5-6gm)and Sapistan Cordia latifolia 9no.(4-5gm) DOSE: 20ml twice daily Sharbate Banafsha 24ml for 7 days 
Comparator Agent  Tab. Levocetrizine Hydrochloride 5mg OD  Levocetrizine Hydrochloride Form:- Tablet Route:- Oral Dose:- 5mg Once a Day  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex in the age group of 18-60 years.
Patient clinically diagnosed to be having uncomplicated Common cold.
Patient who signs the consent paper and follow up protocol  
 
ExclusionCriteria 
Details  Patient age below 18 year and more than 60-year male or female were
excluded
Patients with any complication of Common cold
Common cold associated with any other systemic, metabolic or chronic
disease
• Mentally retarded patients
• Patient malignancy of nose and throat
• Patients not given consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in Common cold Questionaire (CCQ)
2. Reduction in Visual Analogue Scale (VAS) 		 0,3 and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in symptoms  0, 3 & 7 day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/09/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The viral rhinosinusitis commonly known as Common cold and Coryza .It is the most commonly encountered infectious disease of human beings. The term “Common cold” tends to imply that there is a single cause of the illness . The Common cold is caused by airborne viruses, mainly rhinoviruses and coronavirus. Other viruses are adenovirus, influenza, para influenza virus, respiratory syncytial viruses, and enteroviruses . Incubation periods is 1-4 days and illness last for 2-3 weeks . Clinical features begins with, the burning sensation at the back of the nose soon followed by rhinorrhoea, nasal stuffiness and sneezing. Patient have low-grade fever with chilly sensations. Initially, nasal discharge is watery and profuse but due to secondary bacterial (Streptococcus heamolyticus, pneumococcus, Staphylococcus, Heamophilus influenza Klebsiella pneumoniae and Moraxella catarrhalis) infection it may become mucopurulent . Adults are likely to suffer from two to five episodes of Acute Rhinosinusitis (ARS) per year and children seven to ten episodes per year. Zukam as a term use for dribble of fluid (drip of fluid or flows of fluid) from the inflammed nasal mucosa Zukam is the Nazla of Nasal Mucosa. Zukam wa Nazla different in their drip of site means Zukam drip off towards anterior nasal opening and Nazla towards throat and chest. Nazla wa zukam caused by fuzlate dimagh and both are similar due to site of origin of fluid. The prevalence of ARS (Acute Rhinosinusitis) is high, affecting 6-15 percent of the population, and increases in winter months, climatic variations, damp environments and air pollution . Common colds accounts for 40% of all time lost from jobs and 30% of all absenteeism from school . The complications of Common cold may be sinusitis, pharyngitis, tonsillitis, bronchitis, pneumonia, and otitis media . As per 2019 report of the National Health Portal of India about 41,996,260 cases and 3740 deaths from respiratory infection were recorded across India in 2018.Line of treatment of Common cold or Coryza in allopathic medicine are Anti histamine, Nasal decongestant and analgesics but they give symptomatic relief only . Antihistamines most common adverse effect are sedation, diminished alertness and concentration, light headness, motor inco-ordination, fatigue, and tendancy to fall asleep. Acute overdose produces central excitation, tremors hallucinations, muscular incoordination, convulsions, flushing, hypotension, fever and some other features of belladonna poisoning. Death is due to respiratory failure and cardiovascular failure. Fexofenadine not entirely safe in patients with long QT, bradycardia or hypokalemia. Cetrizine leads mild sedation, subjective samnolence. When the patient used nasal decongestant (like oxymetazoline and xylometazoline) for repeated and longer use rhinitis Medicamentosa may develop . Regular and repeated use of these medicine leads to much of side adverse effect and develops drug tolerance On the basis of Unani concept Common cold (Coryza) are similar to zukam. By adopting the principles and formulations of Unani medicine. We can prevent complication as well as adverse effect of Antihistamine, decongestants, and steroids. In our ancient Unani literature, there are a number of formulations for the treatment of Zukam (Common cold and Coryza). Due to holistic approaches Unani system is unique in its method of diagnosis and treatment. The Unani system uses musakkin and lesdaar medicines to converts thin and watery discharge into thick discharge . These medicines are in natural form so they have negligible side effect. Because of the frequently used of steroid and today’sfood habits and changes in life style the immune system becomes weak. So there has been a regular rise in the incidence of Zukam (Common cold). In modern system there is not such any proper medicine which work together for the immune system as well as which is curable for Coryza. Therefore, there is need to develop alternative Unani therapeutic modalities for the treatment of Zukam (Common cold). Fortunately, Unani system of medicine offers a very effective treatment for Zukam by keeping this background in the mind this study is being drawn after very comprehensive and thorough review of clinical Unani literature regarding sign & symptoms, clinical examination, medical management. Hence in this study, planned to treat case of Zukam (Common cold) with the line of treatment and adopted  by Unani physicians, so this has been designed to find out the efficacy of Unani formulation in Zukam (Common cold).  
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