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Wudpecker Journal of Medicinal Plants ISSN 2315-7275

Vol. 2(2), pp 016 - 020, June 2013 2013 Wudpecker Journals

Clinical evaluation of herbal coded formulation


pharinjaline in the treatment of pharyngitis and sore
throat
1
Aamir Abd-ur-Rahman Soomro, 1Halima Nazar, 1Afzal Ahmad, 1Ejaz Mohiuddin, 1Khan
Usmanghani, 2*M. Akram, 2H. M. Asif
1
Faculty of Eastern Medicine, Hamdard University, Karachi, Pakistan.
2
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 million people around the World are affected annually. In
all the painful conditions of the throat. The clinical Pakistan, 12% in the people of above 25 years of age are
presentation of this disorder, however, simulates with that affected annually. In view of the high prevalence of sore
of pharyngitis and tonsillitis, which is more prevalent in throat and the safety concerns related with the main
children. This type of ailment is difficult to manage partly stream drugs, used for its treatment, present study was
because of the complex pathophysiology of the disease. designed to evaluate the efficacy of herbal coded
Moreover, the available drugs either to treat it or provide formulation in patients of sore throat.
symptomatic relief, cause some serious toxicity and Pharyngitis and sore throat most often are caused by
adverse drug reaction (ADR). Younger patients, who direct infection of the pharynx, primarily by viruses or
frequently suffer from this disease, are more susceptible bacteria (Robert et al., 2002, Lawrence et al., 2001). The
for sore throat. pharynx is responsible for adjoining the nasal cavity and
Therefore, a therapy to treat the disease has always the oral cavity to the larynx (which belongs to the
been welcomed and appreciated. Approximately 190 respiratory system) and the esophagus (which belongs to
017 Wudpecker J. Med. Plants

the digestive system (Gray et al., 1992, Sinnatamby, sore throat were interviewed immediately and upon their
1999; John, 2000). There are many agents which cause consent to participate they were grouped as test and
pharyngitis. Viral infections account for approximately control groups. The analysis and evaluation on an
70% of all pharyngitis, with bacteria causing 20 to 30% of intention to treat basis was included and only those
pharyngitis and 30 to 40% are idiopathic. There is no participants who were willing to undergo treatment and
clinical evidence that bacterial sore throats are more were willing as well to attend all the follow up visits during
severe than viral ones or that the duration of the illness is the clinical trial were chosen. The 100 patients were
significantly different in either case (Barbara et al., 2006). randomized to the Pharinjaline and Erythromycin groups:
Clinical presentation of pharyngitis generally includes 50 were treated with coded herbal formulation
sudden onset of throat pain, difficulty in swallowing and Pharinjaline and 50 were treated with Erythromycin.
fever higher than 101 degree Fahrenheit, tender anterior
cervical nodes, and soft palatal petechiae, congestions
over the posterior pharynx, tonsillar enlargement and Data collection
purulent tonsillar exudates. Some atypical symptoms may
also be present with the infected individual such as Data collected for this research work included filling of
mouth breathing, nausea, vomiting, abdominal pain, and clinical trial proforma through personal Interview,
diarrhea (Pechère et al., 2004; Peltola, 1982). 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
MATERIALS AND METHODS physician for record and utilized in statistical assessment.

This is case control direct, unicenter, prospective


randomized authentic allopathic controlled, two arm Statistical analysis
parallel group clinical trial. The clinical assessment
included the improvement cough, fever, odynophagia, Statistical analysis were performed using SPSS and
tender anterior cervical nodes, and tonsillar swelling or excel software, the Chi Square Test was determined. All
exudates. 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.
Subjects

One hundred patients, who had no health problem Inclusion criteria


records in the physical check up, participated in this
study. The ethics committee at Hamdard University The cases were selected on the following lines:
Karachi (Pakistan) approved the study protocol. All
subjects signed informed consent documents. Sample  The patients suffering from pharyngitis and sore
size estimated in clinical assessment on pharyngitis and throat
sore throat has been carried out based on general  Patients living in Gadap Town, Karachi
physical examination, general appearance of the  Patients having no obvious pathological finding on
patients, age, sex, and local examination of the mouth routine examination
and throat in a pilot study at Shifa ul Mulk Memorial  All socioeconomic classes including lower middle and
Hospital. Trial was conducted on 100 patients suffering higher.
from pharyngitis and sore throat from both groups (50  Male and female patients between 18 to 50 years of
patient from control and 50 from experimental group) age
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. Exclusion criteria

The major exclusion criteria for this trial were:


Sample selection
 Patients belonging to the distant area outside
The sample was selected from the out patient department Karachi were excluded because of inherent
registered and enrolled in Shifa ul Mulk Memorial difficulty in following up.
Hospital and on the basis of clinical sign and symptoms  Chronic and secondary infectious cases were
and fulfilling the pharyngitis and sore. Inclusion and excluded.
exclusion criteria are below enumerated. Among this
 Patients having chronic infections e.g.
population, all the patient suffering from pharyngitis and
tuberculosis, leprosy or neoplastic events in the
Soomro et al. 018

Table 1. Age group distribution.

Treatment group
Total
Age group Test (n) Control (n) (n)
(Pharinjaline) (Erythromycin)
18 – 21 Years 4 1 5
22 – 25 Years 8 2 10
26 – 29 Years 4 0 4
30 – 33 Years 8 2 10
34 – 37 Years 9 13 22
38 – 41 Years 10 12 22
42 – 45 Years 6 16 22
46 – 50 Years 1 4 5
Total 50 50 100

Table 2. Fever in total patients at baseline.

Treatment group
Total
Complaint at baseline Control p value
Test (Pharinjaline) (n)
(Erythromycin)
100 to < 101 4 4 8
101 to < 102 20 20 40
Fever 102 to < 103 26 21 47 0.058
103 to < 104 0 5 5
Total 50 50 100

medical history were considered reason for and advantageous. Herbal demulcent have been
exclusion. established for the treatment of sore throat over
 Patient having history of adverse reaction to any generations in many systems of Traditional Medicine and
of the study drugs. they offer a safe alternative to other therapies.
Pharinjaline, one of the well established traditional herbal
preparations for acute pharyngitis available in Pakistan
DISCUSSION has been evaluated in this study under case control
study.
The results of this study show that Pharinjaline, an herbal The study has shown that Pharinjaline is significantly
demulcent remedy, is an efficacious and safe superior to allopathic medicine and provided a rapid relief
symptomatic treatment for sore throat in patients of pharyngitis and sore throat. Herbal coded formulation
suffering from acute pharyngitis as shown in table 2, 3, 4, contains medicinal plants, commonly used in Unani
5, 6 and 7. In the majority of cases acute pharyngitis is a medicine. Although the pharmacological activities of
viral infection while a bacterial infection is shown in these medicinal are already published, this formulation is
approximately 25% of cases. Nevertheless, antibiotics investigated for its efficacy to treat sore throat infection.
are frequently prescribed, as physicians may want to Studies indicate that medicinal plants used in this
fulfill (putative) patients’ expectations. On the contrary, formulation have antibacterial properties. Use of this
reattendance to the clinic may even be higher following a formulation in sore throat is very encouraging and
coarse of prescribed antibiotics, as such prescriptions indicates this formulation should be studied more
may “medicalize” a self-limiting disease. extensively to confirm its mechanism of action.
Additionally, the use of antibiotics is associated with Products from natural sources have been replaced
side effects affecting the individual and the community because of their efficacy and fewer and no side effects
(e.g., diarrhea, rashes, candidiasis, unplanned pregnancy (Bartel et al., 1999, Henkel et al., 1999, Verdine, 1996).
secondary to oral contraceptive. Considering their impact The coded herbal formulation Pharinjaline for Pharyngitis
on bacterial resistance, the use of antibiotics for sore and sore throat treatment comprises of, Aconitum
throat is not without risks. heterophyllum and Atropa acuminate. The medicinal
In this situation a form of therapy influencing the plants Aconitum heterophyllum and Atropa acuminate
subjective symptoms of acute pharyngitis without the have been used traditionally in medicine for decades.
negative aspects of antibiotics is considered appropriate Their anti inflammatory, antispasmotics and anti-pyretic
019 Wudpecker J. Med. Plants

Table 3. Fever in total patients after treatment.

Treatment Group
Total
Complaint at baseline Control P value
Test (Pharinjaline) (n)
(Erythromycin)
98 to < 99 50 49 99
After
Above 99 00 01 01 1.00
treatment
Total 50 50 100

Table 4. Odynophagia in Total Patients at Baseline.

Treatment group
Total
Complaint at baseline Control P value
Test (Pharinjaline) (n)
(Erythromycin)
Severe 16 17 33
Moderate 30 31 61
Odynophagia 0.695
Mild 4 2 6
Total 50 50 100

Table 5. Odynophagia in total patients at after treatment.

Treatment group Total


Complaint at after treatment P value
Test Control (n)
Complete Improvement 48 41 89
Odynophagia Mild Odynophagia 02 09 11 0.02
Total 50 50 100

Table 6. Tonsillar pillar in total patients at baseline.

Treatment group
Total
Complaint at baseline Control P value
Test (Pharinjaline) (n)
(Erythromycin)
Congested 33 28 61
Exudated 09 11 20
Tonsillar Pillar 0.581
Normal 08 11 19
Total 50 50 100

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

Treatment Group Total


Complaint at after treatment P value
Test Control (n)
Complete Improvement 42 34 76
Tonsillar Pillar Congested 00 05 05 0.02
Total 42 39 81

effects have been used very effectively other than their 6-dehydroacetylsepacontinine and 13-
use in coryza, and other illnesses(Usmanghani et al., hydroxylappacontine along with other known
1996). It was so discovered with research and clinical trial norditerpenoid alkaloids namely lycoctonine, delphatine
that the two new compounds isolated from the Aconitum and lappaconitine (Manzoor et al., 2008). This
heterophyllum displayed a significant antibiotic comparative study was conducted to explore the
activity(Ahmad et al., 2008). These two compounds are pharyngitis and sore throat patients with herbal
Soomro et al. 020

formulation as test drug and allopathic as control drug to Barbara B, Jane J (2006). Infection: Microbiology and
assess their efficacy. Management; upper respiratory tract infection: 122-
135.
Bartel S, Frormann S, Jas G, Bindseil KU(1999).
Conclusion Synergistic use of combinatorial and natural product
chemistry. In Drug discovery from nature: (S. grabley
Pharinjaline (test drug) is more effective than the and R. Thiericke, Eds), Springer, Berlin, Heidelberg,
Erythromycin(control drug). in the treatment of pharyngitis New York, 72-105.
and sore throat. Control drug showed lesser efficacy than Gray RF, Hawthorne M (1992). Anatomy of the mouth
the test drug in its compliance to treat pharyngitis and and pharynx in synopsis of otolaryngology, Eds. Butter-
sore throat. Moreover the patient’s satisfaction to cure Worths, London/Boston, Edition 5, Chapter 11:288-305
pharyngitis and sore throat was very well received in Henkel T, Brunne RM, Muller H, abd Reucgek F (1999).
patients prescribed test drug and found greater Statistical investigation into the structural
acceptability. The results of the current study complementarity of natural products and synthetic
demonstrate that treatment with Pharinjaline(test drug) compounds. Angrew. Chem. Intl. Edu., 38: 643-647.
reduces signs and symptoms as well as eradication of John W (2000). Clinical Bacteriology, Mycology and
infection and that these effects are significantly greater Paracytology; Spicer - Science:28-30.
than those produced by the commonly used Lawrence M, Tierney Jr, Stephen, J McPhee, Manine A
erythromycin. The efficacy of Pharinjaline(test drug) in (2001). Treatment of Pharyngitis, Current Medical
subjects with liver impairment is promising and warrants Diagnosis and Treatment, International Edition, San
further study. Franscisco, California, 751 – 764.
Manzoor A, Waqar A, Mansoor A, Obaidullah,
Muhammad Z, Farzana S (2008). Norditerpenoid
Acknowledgment alkaloids from the roots of Aconitum heterophyllum
Wall. J. Enzyme Inhibition and Medicinal Chem.,
The research was supported by a research grant 23(6):1018-1022.
approved by the Shifa Ul Mulk Memorial Hospital, Pechère J, Kaplan E (2004). Streptococcal Pharyngitis:
Hamdard University Karachi. The authors are grateful to Optimal Manag., 3-12.
the Faculty of Eastern Medicine, Hamdard University Peltola H (1982). Observations on the seasonal variation
Karachi for supporting and providing the Laboratories of the most common acute pediatric diseases in the
facilities. Helsinki area (Finland). J Community Health, 7(3): 159-
170.
Robert L, Souham I, John M (2002), Pharyngitis
Conflict of interests Textbook of Medicine - 4th edition, 622-632.
Sinnatamby CS (1999). Mouth and hard palate, in Last’s
The authors of this manuscript have no financial or Anatomy, Regional and Applied, Churchill Livingston,
personal relationships with other people or organizations Edinburgh, Edition 5, Chapter 13:375-382
that could inappropriately influence or bias the content of Usmanghani K, Simin S (1996). Index of Herb Drugs of
the paper. Pakistan, Department of Pharmacognosy, University of
Karachi, Karachi,19-21
Verdine GL (1996). The combinatorial chemistry of
REFERENCES nature. Nature, 384: 11-13.

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.