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
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
017 Wudpecker J. Med. Plants
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 (Pechère 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
 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
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
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

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 patient’s 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.
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