Journal of Medicinal Plants Research Vol. 6(xx), pp.

xxx-xxx 23 April, 2012

Available online at http://www.academicjournals.org/JMPR
DOI: 10.5897/JMPR11.xxxxx12-025
ISSN 1996-0875 2012 Academic Journals





Full Length Research Paper

Clinical evaluation of herbal medicine for essential hypertension

Muhammad Naseem Qasmi, Khan Usmanghani, Abdul Hannan, Halima Nazar, Shahab Uddin, E. Mohiuddin and
M. Akram

Faculty of Eastern Medicine, Hamdard University, Karachi, Pakistan.

Accepted 27 January 2012

In the present study, clinical efficacy of herbal coded formulation (Hypoff) as treatment of essential
hypertension was investigated. This was case control multicenter prospective randomized authentic
allopathic control clinical trial. Open randomized descriptive study was employed in this study. The
drug Hypoff was prescribed to test group while Captopril was prescribed to control group who were
registered at Qasmi Clinic located at Orangi Town, North Nazimabad and Gulshan-e-Iqbal at Karachi.
They all belong to urban population of Karachi. The age range of patients was 25 to 70 years. The
response of the treatment on symptomatology of essential hypertension was analysed. Hypoff was
found to be an economical, safe and effective drug for essential hypertension treatment and was
statistically significant at P<0.03.

Key words: Hypoff, Captopril, clinical trial, efficacy.


INTRODUCTION

Population studies suggested blood pressure (BP) is a
continuous variable, with no line of demarcation between
normal and abnormal values (Kannel, 1996; Collins et al,
1990).
As such, high blood pressure is, therefore, inferred as a
leading risk factor for heart ailment, stroke, and kidney
failure. This correlation is more robust with systolic than
with diastolic BP. Even when BP is lowered by
antihypertensive drugs, the associated reduction in the
incidence of coronary heart ailments lags behind that of
stroke (Laragh and Blumenfeld., 2000; Reaven et al.,
1996; Higashi et al., 1997; Campese et al., 1996; Barba
et al., 1996). In present study, coded herbal formulation
Hypoff was evaluated for treatment of hypertension. This
formulation comprises of Dorema ammoniacum, Nepeta
hindostana, Rauwolfia serpentina, Valeriana officinalis
and Bombyx mori, and the literature search are
delineated herewith.
This is case control directed multicentre prospective
analysis evidence based assessment research work
conducted at Qasmi Clinic located at Orangi Town, North
Nazimabad and Gulshan-e-Iqbal at Karachi, on patients
residing in the urban population.




*Corresponding author. E-mail: makram_0451@hotmail.com.
MATERIAL AND METHODS

Selection criteria of male and female patients aged 25-70 year with
essential hypertension with sitting DBP 90 and >140mm Hg were
included in this study. The test group patients were prescribed
unani formulation Hypoff which comprises of different herbal crude
drug. The control groups were administered allopathic drug
Captopril.
The patients included in the trial were those reporting to the
Outpatient Department. They were thoroughly examined for clinical
signs and symptoms. Their blood pressure and pulse rates were
recorded. Patients with all grades of hypertension, that was either
newly detected or resistant to previous drug therapy were informed
about the trial and were enrolled after signing a consent form. A
chest film, ECG, fundoscopy and serum sodium, potassium,
creatinine, cholesterol, SGOT, glucose, haemoglobin, total WBC
count and urine analysis were performed. Patients with satisfactory
results for these studies were considered for drug therapy. Patients
with recent history of myocardial ischaemia, congestive cardiac
failure, left ventricular failure, renal failure or cerebrovascular
accidents were excluded from the study.
Sixty patients (aged 18-65 years) were randomized to receive
Hypoff (Dorema ammoniacum = 3 g, Nepeta hindostana= 3 g,
Rauwolfia serpentina= 2 g, Valeriana officinalis= 3 g and Bombyx
mori= 5 g) in the double-blind, parallel group trial.
Then the patients received either 800 mg capsule = 0 size
capsule, two capsule twice a day BID equally divided doses for one
to three month. Selection of doses was on the basis of our clinical
practice and doses were adjusted whenever necessary. Blood
pressure and pulse rate were recorded in the supine position by the
same physician / Hakim at the same time of the day at weekly
intervals, using the same sphygmomanometer. The mean of three




readings was noted. At the end of 4 weeks of drug therapy, chest
X-ray, ECG and laboratory investigations were repeated, drug
therapy was tapered off and patients numbers were decoded.
Results are expressed as mean SEM. A patient was categorized
as a responder if his or her diastolic blood pressure at the end of
the study period was less than 95 mmHg (accepted by
WHO) or if there was a fall of 20 mmHg or more in diastolic blood
pressure as compared to the initial value.
For comparison of the antihypertensive activity of these 2 agents,
reduction in diastolic B. P. from 0 to 4 weeks was calculated as the
area under the curve (AUC) using the trapezoidal rule. For
statistical analysis, the Chi square and Fishers exact test were
carried out. All differences were considered statistically significant
by generating a p-value from test statistics. The significant result
with p-value less than 0.05 was defined as statistically significant.


Inclusion criteria

The cases suffering from moderate to mild hypertension were
selected on the following lines.

Patients between age group of 25 to 70 years.
Patient having no obvious pathological findings on routine
examination.
Patients living in Karachi, Pakistan.
All socio-economical classes including lower, middle and upper.


Exclusion criteria

The cases were excluded on the following lines.

Patient with concurrent physical illness, for example, uncontrolled
diabetes and diabetic nephropathy.
Patient with hepatic or renal impairment.
Patient belonging to area outside Karachi because of inherent
difficulty in follow up.
Pregnant women.
History of myocardial ischaemia
Congestive cardiac failure
Left ventricular failure
Renal failure or cerebrovascular accidents were excluded from the
study.


Sample size

Sample size estimation in this clinical study has been done based
on general physical examination, general appearance of the
patients, age, sex, and local examination of the blood pressure
measurement in a pilot study at Qasmi Matabs. This pilot study
included 100 cases each administered with herbal as test drug and
allopathic medicine as control.


Sample selection

The sample was selected from the outpatient enrolled in Qasmi
Matab and on the basis of preliminary clinical examination, the
patients who were suffering from blood pressure were referred to
the project Hakim and upon the basis of inclusion and exclusion
criteria, the patient mashed as candidate were selected. The study
period include 2 years time from 2007 to 2009. Among this
population, the entire patients suffering from hypertension were
interviewed immediately and upon their consent to participate they
were grouped as case and control group.




Data collection

Data collected for this study included filling questionnaire through
personal interview, personal observation, use of case record, file
and documents. The clinical trial proforma attached here which
clearly specifies the clinical feature and information. Calculations
were carried out using the following formulas:

Class interval = 1 + 3.3 log(n)

Range = largest observation Smallest observation

Class size = Range/Class Interval


Statistical analysis

Statistical analysis were performed using SPSS in cooperation with
Mr. Syed Tashfeen Akhter, Assistant Manager, Takaful Pakistan
Limited, using excel software, the Chi square and the Fishers exact
test. All differences were considered statistically significant by
generating a p-value from test statistics. The significant result with
p-value less than 0.05 was defined as statistically significant.


Study limitations

The data was adjusted based on the number of cases in the light of
demographic factor using statistical methods like multinomial
logistic regression. The data were composed in separate group.
The groups were compared after random selection of subject in
equal proportion using SPSS software. The subjects were divided
into two groups, the case and the control groups. Finally,
comparison was carried out between the case and control groups
separately.


Ethical issues

Ethical committee clearance and permission was obtained
whenever necessary considering the followings:

Informing each participant of the study and interviewing and
examining the patient who consented to participate in the study.
Identity will not be revealed and the data would be kept strictly
confidential.
Copy of the entire data will be made available to the Shifa ul Mulk
Memorial Hospital.


RESULT AND DISCUSSION

This study was under taken as an observational
paradigm in which an attempt was made to explore the
essential hypertension patients with herbal and allopathic
medicine so as to asses their efficacy. The diagnosis of
essential hypertension was established by detecting
elevated blood pressure more than 140/90 mm Hg by
sphygmomanometer measurement on three different
occasions within two weeks and the standard clinical trial
proforma was filled for registration. Different parameters,
that is, age, sex, duration, blood pressure, and other
clinical sign and symptoms base line were studied and
compared between two groups at base line and end of
therapeutic applications. All these data were analyzed




Table 1. Mean distribution by treatment group.

Treatment group Mean Number (n) Std. deviation
Test drug (Hypoff)
Male 46.76 33 13.328
Female 41.00 17 9.260
Total 44.80 50 12.312
Control drug (Captopril)
Male 39.86 28 10.693
Female 42.05 22 10.887
Total 40.82 50 10.724
Total
Male 43.59 61 12.578
Female 41.59 39 10.094
Total 42.81 100 11.660



Table 2. Distribution of age group in total patients.

Age group (Years)
Treatment group
Total (n)
Test (n) Control (n)
25 30 3 8 11
31 36 12 9 21
37 42 13 18 31
43 48 6 4 10
49 54 3 1 4
55 60 4 9 13
61 66 6 0 6
67 72 3 1 4
Total 50 50 100



by Chi-Square and the level of significance were applied.
A comparative study was conducted for Hypoff with
Captopril. The present study was undertaken to evaluate
the therapeutic efficacy of these medicine for essential
Hypertension.
The therapeutic evaluations of these medicines were
conducted on 100 clinically diagnosed cases of
Hypertension at Matab Qasmi Clinic located at Orangi
Town, North Nazimabad and Gulshan-e-Iqbal in Karachi,
on patients residing in the urban populace.
These data was collected in the years from February,
2007 February, 2009 which completed the clinical trial
protocol at baseline. Form the collected data of 100
patients enrolled into the study, 61 (61%) and 39 (39%)
were male and female patients, respectively. These 100
patients have been selected out of 140 patients not only
according to exclusion and inclusion criteria. Table 1
shows that there is no significant difference between the
mean of age of the all patients, which are assigned for
Hypoff as well as allopathic Captopril.
The patients gender, age, and baseline clinical
features at the time of enrolment were recorded in both
treatment arms. So overall, 100 patients were selected
and 50 patients assigned to (50%) herbal coded
formulation (Hypoff) and 50 patients (50%) for allopathic
Captopril. The age distribution of over all patients for
Hypoff and Captopril are shown in Table 2.


Conclusion

This prospective study has clearly shown the benefits of
initiating treatment with unani medicine and that, both the
test and control drug was associated with higher blood
pressure and greater reduction in both systolic and
diastolic blood pressure from the base line. In conclusion,
therapies resulted in early improved blood pressure with
tolerability as compared with starting treatment with the
dosage form design for patient with essential
hypertension. The study was not designed to
demonstrate complete treatment strategy approach for
hypoff based regiven, but in primary care setting, if
captopril exhibit adverse reaction, then hypoff could be
used in a tapering fashion, thereby improving blood
control rates for patients with primary essential
hypertension.
A significant portion of hypertension patients receiving
conventional treatment can also use unani therapy for
essential hypertension. Physician need to be aware of
this practice, understand the rationale of this health




Hypertension

Sign and symptoms After applying test of significance with chi square p-value (P<0.05)
Headache
At base line No significant difference between test and control groups 0.351
After treatment No significant difference between test and control drugs 0.177
General weakness
At base line No significant difference between test and control groups 0.161
After treatment Significant difference between test and control drugs 0.003
Irregular beat
At base line No significant difference between test and control groups 0.305
After treatment Significant difference between test and control drugs 0.008
Essential hypertension
At base line No significant difference between test and control groups 1
After treatment Significant difference between test and control drugs 0.026



seeking behavior, proactively enquire about their use and
counsel patients regarding some of these therapies for
adverse reactions and drug interactions.


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