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Clinical trial of Boswellia
Serrata (Shallaki) in the treatment of Osteoarthritis
Introduction:
Osteoarthritis
of the knee joint is a common problem presenting as pain and
progressive disability. Although arrest of degenerative
changes is difficult the treatment is aimed at making the
patient symptom free and mobile as far as possible. Drug
treatment of Osteoarthritis being prolonged, the drug
selected should be free of side effects.
Materials
and method:
Patients
complaining of pain in the knee joints, stiffness and
difficulty in walking and or climbing were included in the
trial. The diagnosis of osteoarthritis was established from
history, physical examination and X Ray changes of the
affected joint. The patients selected were divided into two
groups – one group of patients received Shallaki tablets,
while the other group of patients were given paracetamol
tablets.
Doses:
Shallaki
200mg twice a day for 1st week, 200mg three times
a day for 3 weeks.
Paracetamol
500mg three times a day for 4 weeks.
Details
of age, sex, duration of illness and previous treatment
received are as follows:
|
Age
in years
|
30
– 40
|
40
– 50
|
50
– 60
|
60
– 70
|
70
– 80
|
|
Shallaki
|
5
|
10
|
18
|
11
|
10
|
|
Paracetamol
|
4
|
20
|
22
|
3
|
1
|
|
Sex
|
Male
|
Female
|
|
Shallaki
|
21
|
33
|
|
Paracetamol
|
24
|
26
|
|
Duration
of pain
|
Less
than 1 month
|
1
– 6 months
|
6
months to 2 years
|
More
than 2 years
|
|
Shallaki
|
8
|
25
|
18
|
3
|
|
Paracetamol
|
3
|
20
|
17
|
10
|
|
Previous
treatment taken
|
Nil
|
Oxyphen
- butazone
|
Aspirin
|
Oxyphen
– butazone + aspirin
|
Analgin
|
Ibupofen
|
Paracetamol
|
|
Shallaki
|
14
|
10
|
2
|
17
|
1
|
5
|
1
|
|
Paracetamol
|
6
|
32
|
1
|
11
|
-
|
-
|
-
|
Investigations:
All
patients were subjected to following investigations before
and after treatment. RBC, Haemoglobin, WBC, ESR, Platelet
count, SGOT, SGPT, Stool, Urine and X-Rays of the knee
joints.
|
X
Ray changes
|
Normal
|
Mild
|
Moderate
|
Severe
|
|
Shallaki
|
37
|
9
|
6
|
2
|
|
Paracetamol
|
38
|
11
|
1
|
-
|
Observations:
All
patients were clinically assesses regarding pain,
tenderness, swelling, spasm and range of movement.
Weekly
observations noted and tabulated.
Criteria
for results
Excellent
–
1.
Pain relieved within 1 week after starting treatment
2.
Complete relief of stiffness in 1 week
3.
Full range of movement
4.
75% relief of pain in 1st week
5.
no tenderness around joint after 1 week
Good
–
1.
Pain relief in 2nd and 3rd week
2.
Stiffness decrease in 2nd or 3rd
week
3.
50% to 75% relief of pain after 4 weeks
4.
no tenderness after 4 weeks
5.
full range of movement but terminal 5% slightly
occasionally painful
Fair
–
1.
Pain relieved in last week with presence of
tenderness or morning stiffness
2.
25% to 50% relief of pain in 4 weeks
3.
acceptable increase in movement full range possible
but painful terminally
Poor
–
1.
No relief at all after 4 weeks of treatment
2.
Those who were receiving Oxyphenbutazone or Aspirin
before complained more pain with increased joint stiffness
and restriction of movement
3.
All movements painful and limited
Relief
of Pain
|
Duration
in weeks
|
Excellent
|
Good
|
Fair
|
Poor
|
|
1
|
4
|
1
|
-
|
-
|
|
2
|
2
|
6
|
-
|
-
|
|
3
|
1
|
17
|
4
|
2
|
|
4
|
-
|
2
|
2
|
2
|
|
No
relief
|
-
|
-
|
2
|
9
|
Relief
in stiffness
|
Duration
in weeks
|
Excellent
|
Good
|
Fair
|
Poor
|
|
1
|
2
|
-
|
-
|
-
|
|
2
|
1
|
4
|
-
|
-
|
|
3
|
1
|
13
|
3
|
1
|
|
4
|
-
|
1
|
-
|
1
|
|
No
relief
|
-
|
5
|
-
|
6
|
|
Nil
|
3
|
3
|
5
|
6
|
Results
of Shallaki and Paracetamol after 4 weeks of trial –
|
Drug
|
Total
no. of patients
|
Excellent
|
Good
|
Fair
|
Poor
|
|
Shallaki
|
54
|
7
|
26
|
8
|
13
|
|
Paracetamol
|
50
|
0
|
2
|
12
|
36
|
The
patients on paracetamol did not show improvement in pain or
stiffness in 4 weeks
Conclusion:
After
4 weeks of trial it was observed that, 7 patients taking
Shallaki showed excellent response these cases were having
short duration of complaints (less than 6 months). They had
no radiological changes.
26
cases showed good response. In these patients duration of
complaints was more than 6 months with minimal changes of
osteoarthritis on X-Ray examination. If treatment with
Shallaki had continued for longer period, patients would
have shown excellent results.
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