Wudpecker Journal of Medicinal Plants Vol.

2(2), pp 016 - 020, June 2013

ISSN 2315-7275 2013 Wudpecker Journals

Clinical evaluation of herbal coded formulation pharinjaline in the treatment of pharyngitis and sore throat
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Aamir Abd-ur-Rahman Soomro, 1Halima Nazar, 1Afzal Ahmad, 1Ejaz Mohiuddin, 1Khan Usmanghani, 2*M. Akram, 2H. M. Asif
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Faculty of Eastern Medicine, Hamdard University, Karachi, Pakistan. Department of Eastern Medicine and Surgery, Faculty of Medical and Health Sciences, The University of Poonch, Azad Jammu and Kashmir. *Corresponding author E-mail: makram_0451@hotmail.com. Accepted 27 March 2013 Background: Researchers are constantly in search of safe and active agents of synthetic or herbal origin. Thorough literature review of ancient and modern herbal pharmacology reveals that there are many plants having beneficial activities for health. Pharinjaline is herbal coded formulation comprises of, Aconitum heterophyllum and Atropa acuminate. The medicinal plants Aconitum heterophyllum and Atropa acuminate have been used traditionally in medicine for decades for treatment of pharyngitis. Erythromycine is commonly prescribed to teat pharyngitis and sore throat. Aims: This study was conducted to evaluate the efficacy of herbal coded formulation (Pharinjaline) compared with erythromycin for the treatment of sore throats and acute pharyngitis. Pharinjaline contains plants that are used in pharyngitis and sore throat in traditional medicine. Methods: One hundred patients with sore throat and pharyngitis were randomly divided into two equal groups, 50 in each group. The test group was treated with Pharinjaline and the control group was treated with erythromycin. The effect of both drugs for the treatment of sore throats and acute pharyngitis before and after treatment was recorded and chi square test was used. Results: Comparison of data recorded by the physician on the variables showed significant differences between test and control groups (p <0.05). The efficacy of the test treated medication (Pharinjaline) was superior than erythromycin (p = 0.03). Conclusion: Pharinjaline is more effective than the erythromycin in the treatment of sore throat and acute pharyngitis. Key words: Pharyngitis, herbal coded formulation pharinjaline, erythromycin, efficacy.

INTRODUCTION Sore throat is a broad term, which encompasses almost all the painful conditions of the throat. The clinical presentation of this disorder, however, simulates with that of pharyngitis and tonsillitis, which is more prevalent in children. This type of ailment is difficult to manage partly because of the complex pathophysiology of the disease. Moreover, the available drugs either to treat it or provide symptomatic relief, cause some serious toxicity and adverse drug reaction (ADR). Younger patients, who frequently suffer from this disease, are more susceptible for sore throat. Therefore, a therapy to treat the disease has always been welcomed and appreciated. Approximately 190 million people around the World are affected annually. In Pakistan, 12% in the people of above 25 years of age are affected annually. In view of the high prevalence of sore throat and the safety concerns related with the main stream drugs, used for its treatment, present study was designed to evaluate the efficacy of herbal coded formulation in patients of sore throat. Pharyngitis and sore throat most often are caused by direct infection of the pharynx, primarily by viruses or bacteria (Robert et al., 2002, Lawrence et al., 2001). The pharynx is responsible for adjoining the nasal cavity and the oral cavity to the larynx (which belongs to the respiratory system) and the esophagus (which belongs to

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the digestive system (Gray et al., 1992, Sinnatamby, 1999; John, 2000). There are many agents which cause pharyngitis. Viral infections account for approximately 70% of all pharyngitis, with bacteria causing 20 to 30% of pharyngitis and 30 to 40% are idiopathic. There is no clinical evidence that bacterial sore throats are more severe than viral ones or that the duration of the illness is significantly different in either case (Barbara et al., 2006). Clinical presentation of pharyngitis generally includes sudden onset of throat pain, difficulty in swallowing and fever higher than 101 degree Fahrenheit, tender anterior cervical nodes, and soft palatal petechiae, congestions over the posterior pharynx, tonsillar enlargement and purulent tonsillar exudates. Some atypical symptoms may also be present with the infected individual such as mouth breathing, nausea, vomiting, abdominal pain, and diarrhea (Pechre et al., 2004; Peltola, 1982). MATERIALS AND METHODS This is case control direct, unicenter, prospective randomized authentic allopathic controlled, two arm parallel group clinical trial. The clinical assessment included the improvement cough, fever, odynophagia, tender anterior cervical nodes, and tonsillar swelling or exudates. Subjects One hundred patients, who had no health problem records in the physical check up, participated in this study. The ethics committee at Hamdard University Karachi (Pakistan) approved the study protocol. All subjects signed informed consent documents. Sample size estimated in clinical assessment on pharyngitis and sore throat has been carried out based on general physical examination, general appearance of the patients, age, sex, and local examination of the mouth and throat in a pilot study at Shifa ul Mulk Memorial Hospital. Trial was conducted on 100 patients suffering from pharyngitis and sore throat from both groups (50 patient from control and 50 from experimental group) between ages of 18 to 50 years irrespective of socioeconomic status (Table 1). Mean age of patients was 32 years with standard deviation of 12. Sample selection The sample was selected from the out patient department registered and enrolled in Shifa ul Mulk Memorial Hospital and on the basis of clinical sign and symptoms and fulfilling the pharyngitis and sore. Inclusion and exclusion criteria are below enumerated. Among this population, all the patient suffering from pharyngitis and

sore throat were interviewed immediately and upon their consent to participate they were grouped as test and control groups. The analysis and evaluation on an intention to treat basis was included and only those participants who were willing to undergo treatment and were willing as well to attend all the follow up visits during the clinical trial were chosen. The 100 patients were randomized to the Pharinjaline and Erythromycin groups: 50 were treated with coded herbal formulation Pharinjaline and 50 were treated with Erythromycin. Data collection Data collected for this research work included filling of clinical trial proforma through personal Interview, personal observation and use of case record, file and documents. The designed clinical trial proforma specified the clinical feature and information to be filled by the physician for record and utilized in statistical assessment. Statistical analysis Statistical analysis were performed using SPSS and excel software, the Chi Square Test was determined. All differences were considered statistically significant by generating a p-value. The significant result with p-value less than 0.05 was considered as statistically significant. Inclusion criteria The cases were selected on the following lines: The patients suffering from pharyngitis and sore throat Patients living in Gadap Town, Karachi Patients having no obvious pathological finding on routine examination All socioeconomic classes including lower middle and higher. Male and female patients between 18 to 50 years of age

Exclusion criteria The major exclusion criteria for this trial were: Patients belonging to the distant area outside Karachi were excluded because of inherent difficulty in following up. Chronic and secondary infectious cases were excluded. Patients having chronic infections e.g. tuberculosis, leprosy or neoplastic events in the

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Table 1. Age group distribution.

Age group 18 21 Years 22 25 Years 26 29 Years 30 33 Years 34 37 Years 38 41 Years 42 45 Years 46 50 Years Total

Treatment group Test (n) Control (n) (Pharinjaline) (Erythromycin) 4 1 8 2 4 0 8 2 9 13 10 12 6 16 1 4 50 50

Total (n) 5 10 4 10 22 22 22 5 100

Table 2. Fever in total patients at baseline.

Complaint at baseline 100 to < 101 101 to < 102 102 to < 103 103 to < 104 Total

Fever

Treatment group Control Test (Pharinjaline) (Erythromycin) 4 4 20 20 26 21 0 5 50 50

Total (n) 8 40 47 5 100

p value

0.058

medical history were considered reason for exclusion. Patient having history of adverse reaction to any of the study drugs.

DISCUSSION The results of this study show that Pharinjaline, an herbal demulcent remedy, is an efficacious and safe symptomatic treatment for sore throat in patients suffering from acute pharyngitis as shown in table 2, 3, 4, 5, 6 and 7. In the majority of cases acute pharyngitis is a viral infection while a bacterial infection is shown in approximately 25% of cases. Nevertheless, antibiotics are frequently prescribed, as physicians may want to fulfill (putative) patients expectations. On the contrary, reattendance to the clinic may even be higher following a coarse of prescribed antibiotics, as such prescriptions may medicalize a self-limiting disease. Additionally, the use of antibiotics is associated with side effects affecting the individual and the community (e.g., diarrhea, rashes, candidiasis, unplanned pregnancy secondary to oral contraceptive. Considering their impact on bacterial resistance, the use of antibiotics for sore throat is not without risks. In this situation a form of therapy influencing the subjective symptoms of acute pharyngitis without the negative aspects of antibiotics is considered appropriate

and advantageous. Herbal demulcent have been established for the treatment of sore throat over generations in many systems of Traditional Medicine and they offer a safe alternative to other therapies. Pharinjaline, one of the well established traditional herbal preparations for acute pharyngitis available in Pakistan has been evaluated in this study under case control study. The study has shown that Pharinjaline is significantly superior to allopathic medicine and provided a rapid relief of pharyngitis and sore throat. Herbal coded formulation contains medicinal plants, commonly used in Unani medicine. Although the pharmacological activities of these medicinal are already published, this formulation is investigated for its efficacy to treat sore throat infection. Studies indicate that medicinal plants used in this formulation have antibacterial properties. Use of this formulation in sore throat is very encouraging and indicates this formulation should be studied more extensively to confirm its mechanism of action. Products from natural sources have been replaced because of their efficacy and fewer and no side effects (Bartel et al., 1999, Henkel et al., 1999, Verdine, 1996). The coded herbal formulation Pharinjaline for Pharyngitis and sore throat treatment comprises of , Aconitum heterophyllum and Atropa acuminate. The medicinal plants Aconitum heterophyllum and Atropa acuminate have been used traditionally in medicine for decades. Their anti inflammatory, antispasmotics and anti-pyretic

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Table 3. Fever in total patients after treatment.

Complaint at baseline After treatment 98 to < 99 Above 99 Total

Treatment Group Control Test (Pharinjaline) (Erythromycin) 50 49 00 01 50 50

Total (n) 99 01 100

P value

1.00

Table 4. Odynophagia in Total Patients at Baseline.

Complaint at baseline Severe Moderate Mild Total

Odynophagia

Treatment group Control Test (Pharinjaline) (Erythromycin) 16 17 30 31 4 2 50 50

Total (n) 33 61 6 100

P value

0.695

Table 5. Odynophagia in total patients at after treatment.

Complaint at after treatment Odynophagia Complete Improvement Mild Odynophagia Total

Treatment group Test Control 48 41 02 09 50 50

Total (n) 89 11 100

P value 0.02

Table 6. Tonsillar pillar in total patients at baseline.

Complaint at baseline Congested Exudated Normal Total

Tonsillar Pillar

Treatment group Control Test (Pharinjaline) (Erythromycin) 33 28 09 11 08 11 50 50

Total (n) 61 20 19 100

P value

0.581

Table 7. Tonsillar pillar in total patients at after treatment.

Complaint at after treatment Tonsillar Pillar Complete Improvement Congested Total

Treatment Group Test Control 42 34 00 05 42 39

Total (n) 76 05 81

P value 0.02

effects have been used very effectively other than their use in coryza, and other illnesses(Usmanghani et al., 1996). It was so discovered with research and clinical trial that the two new compounds isolated from the Aconitum heterophyllum displayed a significant antibiotic activity(Ahmad et al., 2008). These two compounds are

6-dehydroacetylsepacontinine and 13hydroxylappacontine along with other known norditerpenoid alkaloids namely lycoctonine, delphatine and lappaconitine (Manzoor et al., 2008). This comparative study was conducted to explore the pharyngitis and sore throat patients with herbal

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formulation as test drug and allopathic as control drug to assess their efficacy. Conclusion Pharinjaline (test drug) is more effective than the Erythromycin(control drug). in the treatment of pharyngitis and sore throat. Control drug showed lesser efficacy than the test drug in its compliance to treat pharyngitis and sore throat. Moreover the patients satisfaction to cure pharyngitis and sore throat was very well received in patients prescribed test drug and found greater acceptability. The results of the current study demonstrate that treatment with Pharinjaline(test drug) reduces signs and symptoms as well as eradication of infection and that these effects are significantly greater than those produced by the commonly used erythromycin. The efficacy of Pharinjaline(test drug) in subjects with liver impairment is promising and warrants further study. Acknowledgment The research was supported by a research grant approved by the Shifa Ul Mulk Memorial Hospital, Hamdard University Karachi. The authors are grateful to the Faculty of Eastern Medicine, Hamdard University Karachi for supporting and providing the Laboratories facilities. Conflict of interests The authors of this manuscript have no financial or personal relationships with other people or organizations that could inappropriately influence or bias the content of the paper. REFERENCES Ahmad M, Ahmad W, Ahmad M, Zeeshan M, Obaidullah, Shaheen F (2008). Norditerpenoid alkaloids from the roots of Aconitum heterophyllum Wall with antibacterial activity, J Enzyme Inhib Med Chem., 23(6): 1018-1022.

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