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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.
INTRODUCTION
same physician / Hakim at the same time of the day at weekly were grouped as case and control group.
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 Data collection
therapy was tapered off and patients’ numbers were decoded.
Results are expressed as mean ± SEM. A patient was categorized Data collected for this study included filling questionnaire through
as a ‘responder’ if his or her diastolic blood pressure at the end of personal interview, personal observation, use of case record, file
the study period was less than 95 mmHg (accepted by WHO) or if and documents. The clinical trial proforma attached here which
there was a fall of 20 mmHg or more in diastolic blood pressure as clearly specifies the clinical feature and information. Calculations
compared to the initial value. were carried out using the following formulas:
For comparison of the antihypertensive activity of these 2 agents,
reduction in diastolic B. P. from 0 to 4 weeks was calculated as the Class interval = 1 + 3.3 log(n)
area under the curve (AUC) using the trapezoidal rule. For
statistical analysis, the Chi square and Fisher’s exact test were Range = largest observation – Smallest observation
carried out. All differences were considered statistically significant
by generating a ‘p-value’ from test statistics. The significant result Class size = Range/Class Interval
with ‘p-value’ less than 0.05 was defined as statistically significant.
Statistical analysis
Inclusion criteria
Statistical analysis were performed using SPSS in cooperation with
The cases suffering from moderate to mild hypertension were Mr. Syed Tashfeen Akhter, Assistant Manager, Takaful Pakistan
selected on the following lines: Limited, using excel software, the Chi square and the Fisher’s exact
test. All differences were considered statistically significant by
1. Patients between age group of 25 to 70 years. generating a ‘p-value’ from test statistics. The significant result with
2. Patient having no obvious pathological findings on routine ‘p-value’ less than 0.05 was defined as statistically significant.
examination.
3. Patients living in Karachi, Pakistan.
4. All socio-economical classes including lower, middle and upper. Study limitations
The data was adjusted based on the number of cases in the light of
Exclusion criteria demographic factor using statistical methods like multinomial
logistic regression. The data were composed in separate group.
The cases were excluded on the following lines. The groups were compared after random selection of subject in
equal proportion using SPSS software. The subjects were divided
1. Patient with concurrent physical illness, for example, uncontrolled into two groups, the case and the control groups. Finally,
diabetes and diabetic nephropathy. comparison was carried out between the case and control groups
2. Patient with hepatic or renal impairment. separately.
3. Patient belonging to area outside Karachi because of inherent
difficulty in follow up.
4. Pregnant women. Ethical issues
5. History of myocardial ischaemia.
6. Congestive cardiac failure.
Ethical committee clearance and permission was obtained
7. Left ventricular failure.
whenever necessary considering the followings:
8. Renal failure or cerebrovascular accidents were excluded from
the study.
a). Informing each participant of the study and interviewing and
examining the patient who consented to participate in the study.
b). Identity will not be revealed and the data would be kept strictly
Sample size
confidential.
c). Copy of the entire data will be made available to the Shifa ul
Sample size estimation in this clinical study has been done based
Mulk Memorial Hospital.
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 RESULTS AND DISCUSSION
allopathic medicine as control.
This study was under taken as an observational
Sample selection paradigm in which an attempt was made to explore the
essential hypertension patients with herbal and allopathic
The sample was selected from the outpatient enrolled in Qasmi medicine so as to asses their efficacy. The diagnosis of
Matab and on the basis of preliminary clinical examination, the essential hypertension was established by detecting
patients who were suffering from blood pressure were referred to elevated blood pressure more than 140/90 mmHg by
the project Hakim and upon the basis of inclusion and exclusion sphygmomanometer measurement on three different
criteria, the patient mashed as candidate were selected. The study
period include 2 years time from 2007 to 2009. Among this occasions within two weeks and the standard clinical trial
population, the entire patients suffering from hypertension were proforma was filled for registration. Different parameters,
interviewed immediately and upon their consent to participate they that is, age, sex, duration, blood pressure, and other
Qasmi et al. 4191
Treatment group
Age group (Years) 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
clinical sign and symptoms base line were studied and features at the time of enrolment were recorded in both
compared between two groups at base line and end of treatment arms. So overall, 100 patients were selected
therapeutic applications. All these data were analyzed by and 50 patients assigned to (50%) herbal coded
Chi-Square and the level of significance were applied formulation (Hypoff) and 50 patients (50%) for allopathic
(Table 3). Captopril. The age distribution of over all patients for
A comparative study was conducted for Hypoff with Hypoff and Captopril are shown in Table 2.
Captopril. The present study was undertaken to evaluate
the therapeutic efficacy of these medicine for essential
Hypertension. Conclusion
The therapeutic evaluations of these medicines were
conducted on 100 clinically diagnosed cases of This prospective study has clearly shown the benefits of
Hypertension at Matab Qasmi Clinic located at Orangi initiating treatment with unani medicine and that, both the
Town, North Nazimabad and Gulshan-e-Iqbal in Karachi, test and control drug was associated with higher blood
on patients residing in the urban populace. pressure and greater reduction in both systolic and
These data was collected in the years from February, diastolic blood pressure from the base line. In conclusion,
2007 – February, 2009 which completed the clinical trial therapies resulted in early improved blood pressure with
protocol at baseline. Form the collected data of 100 tolerability as compared with starting treatment with the
patients enrolled into the study, 61 (61%) and 39 (39%) dosage form design for patient with essential
were male and female patients, respectively. These 100 hypertension. The study was not designed to
patients have been selected out of 140 patients not only demonstrate complete treatment strategy approach for
according to exclusion and inclusion criteria. Table 1 hypoff based regiven, but in primary care setting, if
shows that there is no significant difference between the captopril exhibit adverse reaction, then hypoff could be
mean of age of the all patients, which are assigned for used in a tapering fashion, thereby improving blood
Hypoff as well as allopathic Captopril. control rates for patients with primary essential
The patient’s gender, age and baseline clinical hypertension.
4192 J. Med. Plants Res.
Table 3. Clinical sign and symptoms of Hypertension before after applying test of significance with chi square p-value.
Sign and symptoms After applying test of significance with chi square p-value (P<0.05)
At base line No significant difference between test and control groups 0.351
Headache
After treatment No significant difference between test and control drugs 0.177
At base line No significant difference between test and control groups 0.161
General weakness
After treatment Significant difference between test and control drugs 0.003
At base line No significant difference between test and control groups 0.305
Irregular beat
After treatment Significant difference between test and control drugs 0.008
A significant portion of hypertension patients receiving Kannel WB (1996). Blood pressure as a cardiovascular risk factor:
Prevention and treatment. JAMA., 275: 1571-1576.
conventional treatment can also use unani therapy for
Laragh JH, Blumenfeld JB (2000). Essential hypertension. In Brenner
essential hypertension. Physician need to be aware of and Rector’s The Kidney, Vol. II 6th ed. Philadelphia : WB Saunders.
this practice, understand the rationale of this health Pp. 1967-2000.
seeking behavior, proactively enquire about their use and Reaven GM, Lithell H, Landsberg L (1996). Hypertension and
associated metabolic abnormalities – the role of insulin resistance
counsel patients regarding some of these therapies for
and the sympathoadrenal system. NEJM, 334: 374-81.
adverse reactions and drug interactions.
REFERENCES