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Ancient Science of Life Vol : XXVI (1 & 2) July, August, September, October, November, December 2006
EFFICACY OF AYURVEDIC MEDICINE IN THE TREATMENT OF
UNCOMPLICATED CHRONIC SINUSITIS.
DR. HEMANTA KUMAR PANIGRAHI M.D(Ay.) Ph.D(Ay.)
Ex- Lecturer, A&U Tibbia College & Hospital, New Delhi.
Research Officer (Ay.), Central Research Institute, Punjabibagh, New Delhi.
Received : 12-4-2006 Accepted : 12-6-2006
Abstract- Thirty patients suffering from uncomplicated chronic Sinusitis were enrolled
in a clinical study to asses the efficacy of Ayurvedic medicine comprising of Tribhvan
kirti rasa (Tablet) along with inhalation of steam of Dasamulakwath (Decoction)
followed by nasya (intranasal instillation) with Anu tailam. The Tribhuvan kirti rasa
was administered at a dose of 250mg b.d with Adrak swaras ( Juice of Ginger).Steam
inhalation of Dasmula kwath was given two times a day followed by nasya of Anu tail at
a dose of 4 drops in both nostrils. The duration of the treatment varied from 45 days to 90
days. Radiological tests were done periodically. The patients were examined clinically in
every week to asses the effect of medicine. The overall clinical efficacy was 96.6%. This
medicine along with steam inhalation followed by Nasya was found to be well tolerated in
general and no side effects were reported. Hence this treatment could be recommended for
treatment of chronic Sinusitis.
INTRODUCTION
Sinusitis is an infection of the Para nasal sinus and the nose,most commonly
caused by Streptococcus pneumoniae, Morexella cattarhalis. Accumulation of
mucus in the sinus secondary to obstruction and inflammation facilitates
pathogen growth. Approximately 30 million Americans develop sinusitis
annually. Clinical symptoms include mucopurulent nasal discharge, nasal
congestion, and facial pain or, tenderness lasting 7 to 28 days during attack.
Diagnosis is therefore often presumptive, being based on clinical presentation
and diagnostic interpretation, and may include culturing. Diagnostic technique
includes sinus radiography, sinus transillumination, sonography, and
computerized tomography.
The clinical features of sinusitis bear resemblance with “Suryavarta” as described
in the Ayurvedic texts. According to Ayurveda, the main dosha involved is vayu
and kapha dosha. Hence steam inhalation of Dasamoola kwatha was chosen for
inhalation followed by nasya of Anu taila.
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The present study is confined to uncomplicated maxillary and frontal sinusitis.
Tribhuvan kirti rasa, a medicine described in Bhaisajya Ratna vali written by
Govinddas (B.S2033) was selected. For steam inhalation Dasamoola Kwatha was
selected followed by Anu tail nasya.
Procurement of Medicines:
The medicines were procured from IMPCL (LTD) and dispensed at Central
Research Institute, New Delhi.
MATERIALS AND METHODS:
Study Design:
This was a randomized non comparative trial performed in OPD of Central
Research Institute Delhi, designed to comply with current food and drug
administration guidance for demonstrating clinical efficacy in the treatment of
chronic uncomplicated sinusitis. Written informed consent was obtained from all
the participating patients before study enrollment.
Eligibility and accrual:
Patients who were eligible to participate in the study included adults (18yrs of
age or, more) whose medical history, physical examination and radiographic
findings suggested chronic uncomplicated sinusitis and in whom oral out patient
therapy was indicated.
Inclusion criteria were facial pain, tenderness over one or both maxillary area,
purulent discharge from back of throat, or, nose. Women of child bearing
potential were required to have a documented negative serum or, urine
pregnancy test before the start of therapy. They also had to sign an agreement
pledging to use effective contraceptive throughout the trial. X-ray (Water’s view)
was done and read by a qualified radiologist and should have been positive at
least for one of the following criteria-
• Opacification or, haziness of sinus.
• >6mm. of mucosal thickening.
• Air fluid level.
Key Exclusion criteria included hyper sensitivity to any of the trial medicine,
complicated sinusitis, cystic fibrosis or, an abnormality of the maxillary sinus
ostium that impaired drainage, history of sinus surgery within 3 months, intake
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of a systemic antibiotic within 14 days of entry into the study, presence of
significant hepatic disease , known renal insufficiency, pregnancy and lactation.
Treatment and Compliance:
Subjects were assigned randomly from OPD of Central Research Institute New
Delhi.
Initially the patients were given Tribhuvan Kirti Rasa 250mg with adrak swaras
(juice of ginger) twice a day. The patients were then advised to inhale steam of
Dasmoola kwatha by a steam inhaler for 15 minutes twice a day. After the
inhalation of steam, the patients were advised to take nasya of Anu tail in a dose
of 4 drops in both the nostrils and lay flat with slightly extended head for 10
minutes. During this period the patients were advised not to take curd, rice, and
banana. The total duration of this treatment was 90 days. No other systemic
antibiotic, anti-inflammatory or, nasal decongestant were permitted during the
course of the study. Compliance was measured by noting the exact dose taken,
reason for missed dose and the amount of study medication returned by the
subjects at the end of treatment.
Study procedure:
The assessment of patients was conducted 4 times –
• Within 48 hours of dosing.
• Day 7 to 15day.
• Day 30 to 45 day.
• Day 60 to 90 day.
At base line, after subject provides written consent, the inclusion criteria and
exclusion criteria were reviewed. Then demographic, medical history, and drug
and non drug therapy were collected. A targeted physical examination, clinical
assessment of sign and symptoms was also done. X-Ray PNS and routine
examination were the investigation procedures. Pregnancy test was done for
women of child bearing potential. At the end of the study, X-Ray was taken and
compared with base line.
Criteria for evaluation :
Clinical response were classified in to three category-
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Clinical success: Resolution or, improvement of three cardinal signs and
symptoms (Sinus pain, sinus tenderness, purulent discharges) with clear X-Ray
PNS, without any additional therapy.
Failure: Persistence or, worsening of signs and symptoms.
Unable to determine: Not taken medicines or fewer than 7 days, received an
additional therapy before evaluation or, lack of follow up.
RESULTS AND DISCUSSION:
Disposition of the patients: All 30 patients completed the study according to
protocol. In a patient, proper follow up was not done however he has completed
the treatment regimen.
Demography: Approximately 2/3rd of all the patients were from Delhi city. The
median age was 39 years (range 18-62). The study population composed of 60%
of women.
Clinical Findings: The most frequently noted symptoms of sinusitis were
purulent nasal discharge (96.66%of patients),nasal congestion( 93.33%),sinus pain
(90%) facial pain (80%) post nasal drip (83.33%) , head ache (90%) and sinus
tenderness (80%)
In 84% of the patients, both maxillary sinus were involved and in 16% of cases it
involves only one sinus.
In 90% of cases, X-Ray on Water’s projection showed opacity in the sinus,
mucosal thickening, or, air-fluid levels . However in 10% of cases , only mucosal
thickening was noted.
Therapeutic Efficacy: Data of all the 30 patients who completed the study was
eligible for analysis. Treatment with Ayurvedic medicine resulted in significant
improvement from week 2 onwards in the following signs and symptoms like
frontal headache, pain over jaw, tenderness and nasal discharges. 13 patients
were completely free from symptoms in 25 days, 7 patients on 35th day, and 8
patients on 47th day.
But all the patients were advised to continue same treatment upto 90 days. The
minimum time required for relief of symptoms was the 25th day .Maximum
duration required for relief of symptoms was observed to be 46th day.
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At endpoint , the radiological examination showed no opacity or haziness in the
sinus which suggested good sinus drainage and proper sinus ventilation. No
evidence of mucosal thickening was found. No signs of ostial edema was found
after treatment.
Safety Evaluation:
No adverse effects or side effects were found during the study.
Table No-1
Showing Age distribution in studied cases
Table No-2
Showing Sex incidence
Table No-3
Duration of present illness
Age in year No. of Patients %
18-28 1 3.34
29-39 21 70
40-50 6 20
50-60 2 6.66
Total 30 100
Sex No of patients %
Male 12 40
Female 18 60
Total 30 100
Duration No. of patients %
6month-1yrs. 17 56.6
1-2yrs. 12 40
2-4yrs. 1 3.33
More then 4 yrs. nil 00
Total 30 100
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Table No-4
No. of Sinusitis Episode in 12 months
Table No. 5 (History of Prior treatment)
Table No-6
Involvement of Sinus
Table NO-7
Radiological Findings
No. of attack No. of Patients %
2 to 3 18 60
4 to 6 12 40
More then 6 Nil 00
Total 30 100
Prior medication No. of Patients %
Systemic Antibiotic 27 90
Surgery Nil 00
No prior Medication 03 10
Total 30 100
Site No of Patients %
Unilateral 12 40
Bilateral 18 60
Total 30 100
Radiological
Findings
BT % AT Relief %
Haziness in Sinus 30 100 0 100
Mucosal thickening 27 90 0 100
Air-Fluid level 30 100 0 100
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Table No-8
Overall assessment of Symptoms
Symptoms BT(No of
pts)
% AT(No. of
pts.)
Relief %
Pain over Sinus 27 90 0 100
Tenderness over sinus 24 80 0 100
Purulentnasal discharge 29 96.66 0 100
Frontal headache 27 90 0 100
Post nasal drip 25 83.33 0 100
Nasal congestion 28 93.33 0 100
Facial pain 24 80 0 100
Table No-9
Overall assessment of efficacy recorded after 3months of Treatment
Degree No. of patients %
Clinical success 29 96.6
Failure 0 0
Unable to determine 1 3.4
Total 30 100
CONCLUSION:
Sinusitis is a common respiratory tract infection which often goes undiagnosed
and untreated. A delay in diagnosis and failure to institute effective therapy may
lead to development of complications like abscess, cellulitis, epidural empyema,
osteomyelitis, and meningitis. This study confirms the anti-inflammatory effect
of Dasmoola kwatha, Tribhuvan kirti rasa and steam inhalation which
potentially sooth the mucous and facilitate sinus drainage. Anu tail helps to
decongest the sinus ostium.
A 90 day course of Ayurvedic medicine was well tolerated, safe, and effective
clinically in adult with uncomplicated sinusitis. The overall clinical success rate
was 96.6%.
On the basis of clinical and radiological findings, it is inferred that indigenous
medicine like Tribhuban kirti Rasa, Dasamoolakwatha inhalation, Anu tail Nasya
proves to be an effective treatment of choice in chronic uncomplicated Sinusitis.
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ACKNOWLEDGEMENT :
Thanks are due to Prof. G.S.Lavekar, Director, CCRAS, New Delhi, Dr.
T.Bikshapati, Director,CRIA, New Delhi Dr. H.K.Khushwah, Dr.K.K.Sijoria, Dr.
B.K.Jaisingh,Dr.M.Panda for their valuable guidance during the study.
REFERENCES
1. Bailey and Love, Short practice of Surgery, 21st edition ELBS publication, 1998.
2. Dhingra, P.L Disease of Ear nose and Throat B.I.Churchill Living stones publication, 2000.
3. Sastri,A.D , Susruta Samhita.Published by Chowkhumba publication.
4. Sastri, Ambika dutta Bhaisajya Ratna vali Commented by R.D Sastry 2nd Edition
Chowkhamba Sanskrit office Varanasi 1969
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