Clinical Study To Evaluate the efficacy of polyherbal Unani formulation in Zukam (Coryza OR Common Cold)

Phase 2/3

Recruiting

Conditions: Unspecified disorder of nose and nasal sinuses,

Registration Number: CTRI/2023/08/056975

Lead Sponsor: State Unani Medical College

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 â€œCommon coldâ€ 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 todayâ€™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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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 â€¢ Mentally retarded patients â€¢ Patient malignancy of nose and throat â€¢ Patients not given consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in Common cold Questionaire (CCQ)	0,3 and 7th day
2. Reduction in Visual Analogue Scale (VAS)	0,3 and 7th day

Secondary Outcome Measures

Name	Time	Method
Reduction in symptoms	0, 3 & 7 day

Trial Locations

Locations (1): OPD/IPD of Ain, Uzn, Anf, Halaq wa Asnan
🇮🇳
Allahabad, UTTAR PRADESH, India
OPD/IPD of Ain, Uzn, Anf, Halaq wa Asnan
🇮🇳Allahabad, UTTAR PRADESH, India
Moh Jishan Gazi
Principal investigator
7830967733
mohdzeeshanoor@gmail.com