A double
blind cross-over trial of R, compound
in
chronic arthritis conditions
by
Dr. V. Radhakrishna Murty M. D., F. C. C. P.
Lakshmi Nursing Home, Ramanaidupet, MACHILIPATHAM
521 001.
MAHARASHTRA MEDICAL JOURNAL
538 Narayan Petli, Kelkar Road, Pune 411 030.
(INDIA)
IN DAILY PRACTICE WE COME
ACROSS MANY PATIENTS WHO COMPLAIN OF PAIN, tenderness, stiffness and limitation
of movement of joints, single or multiple, upper and/or lower extremities,
unilateral or bilateral, and these are vaguely termed as 'Rheumatic pains ' or arthritic pains. The etiology of
rheumatoid arthritis and "other allied diseases is obscure and hence the
treatment is empirical.
The object of this study
is to find out to what extent an Ayurvedic drug R. Compound, is beneficial in
the treatment of chronic arthritic conditions.
Some previous studies on
R. Compound/Ingredients of R. Compound :
1. Toxicity tests were done in London by Herd and Mundy ( 1952 )
who reported as to the safety of R. Compound.
2. Karandikar et al ( 1960 ) published the work on the anti-inflammatory
effect of Guggul in arthritic conditions.
3. Gujral et al (1962 ) published experimental studies on the
ingredients of R. Compound.
4. Published studies on R.
Compound have shown that R. Compound is a useful drug in the management of
arthritic conditions.
5. Controlled studies on R. Compound have shown the beneficial
effects of R. Compound comparable with other anti-inflammatory and analgesic
drugs like salicylates, oxyphenbutazone, etc. without the drawbacks and the
side effects of these drrgs.
Composition of R.
Compound :
R. Compound is a composite
drug containing Mahayogaraj Guggul with gold in Bhasma form and Rasnadi Quath,
processed in Haldi ( Curcuma longa ). This drug is indicated in acute and chronic
rheumatoid and other painful musculoskeletal disoiders and soft tissue
inflammations and trauma.
1. Mahayogaraj Guggul : This is prepared from 30 herbomineral
drugs. Its main ingredient is Guggul ( Balsamodendron mukul ), an eleoresin, which has broad spectrum
properties according to Ayutveda. It has demulscent, carminative, laxative,
antispasmodic, expectorant and haematinic properties. It is said to stimulate,
disinfect and regulate the functions of the organs when it passes through the
mucous membrane of kidneys, skin, genito-urinary tract etc. Guggul stimulates
leucocytosis and promotes phagocytosis. It is anti-inflammatory,
anti-bacterial, antipyretic and anti-anaemic and has soothing effect on the
central nervous system. It is reputed to have marked anti- suppurative
properties and is used in rheumatic, nervous, urinary and skin diseases and
scrofulous affectations.
2. Gold in Bhasma form : Gold in Bhasma form is known to be
non-toxic unlike gold salts used in Western medicine which have toxic effects.
Gold Bhasmais described to act as general metabolic stimulant and to activate
reticuloendothelial system. It acts as metabolic catalyst and brings about a
sense of well-being.
3. Maharasnadi Quath : It is processed from 25 herbal drugs,
its cfiief ingredient being Rasna, which is known to have anti-inflammatory,
analgesic, anti-pyretic, anti-rheumatic, diuretic and detoxicating properties.
Maharasnadi Quath is specially indicated in painful musculo-skeletal conditions
and shows increased efficacy when used with Mahayogaraj Guggul. In the opinion
of R. N. Singh in scientifically evaluated experimental studies with
formaldehyde induced arthritis, croton oil induced granuloma pouch and ` freunds adjuvant induced arthritis in
albino rats, he found that Rasna has remarkable antiinflammatory effect.
(Prasarni, Nirgundi and Bhela also showed similar properties as Rasna in
similar experiments. )
Material and methods:
This study was conducted
during 1978-80. The total number of cases finally analysed was 70. This
excluded 30 cases that could not be followed-up among a total of 100 cases.
All, the cases were treated as Out Patients and hospitalization was not done
in any of these cases. Most of the patients were from the middle socioeconomical
class, followed by upper socio-economic class and lower socio-economic class
in that order.
Plan of study:
Two sets of identically
looking capsules, one marked X and the other marked Y, were supplied. One set
contained R. Compound in powder form, and each capsule was equivalent to one R.
Compound. tablet available with the chemists, and the other set contained
placebo. The identity of X and Y capsules were not revealed to the
investigators till the end of the trial. 35 patients were randomly given X
capsules and 35 patients were randomly given Y capsules during the first ten
days.
The dose of X or Y
capsules during the course of 30 days of clinical trial was two capsules, three
times a day.
For the first ten days, 35
patients received X capsules and the other 35 patients received Y capsules.
Then for the next ten days, Cross-over was made, that is, those who received X
capsules before, received Y capsules and those who received Y capsules before,
received X capsules now. Results were assessed at every ten days.
Those who received X
capsules during the first ten days, and those who received these during the
second ten days as cross-over from Y group, snowed better iesponse. Those who
received Y capsules during first ten days and during second ten days as cross-over
from X group did not show satisfactouy response.
Since X capsules showed
bettei results wh compared to Y capsules during first ten days ana second
cross-over ten days, during the third ten days, only X capsules were given and
iesults were finally assessed.
Age and sex incidence :
There were 20 male
patients ( 28.6 % )' and 50 female patients ( 71.4 % ) in our series. The peak
age incidence was in the age group of 41 - 50 years with 31 patients ( 44.3 %
). 62.9 % were aged over 41 years and 37.1 % were aged lass than 41 years (
Table I ).
|
Table T :Age and sex incidence . |
||||
|
Age group ( years ) |
Males |
Females |
Total |
% |
|
11-20 |
0 |
3 |
3 |
4.3 |
|
21-30 |
3 |
9 |
12 |
17.1 |
|
31 -40 |
3 |
8 |
11 |
15.7 |
|
41 - 50 |
9 |
22 |
31 |
44.3 |
|
51 -60 |
3 |
6 |
9 |
12.9 |
|
61 -70 |
2 |
1 |
3 |
4.3 |
|
71-80 |
0 |
1 |
1 |
1.4 |
|
Total |
20 |
50 |
70 |
100.0 |
|
Percentage |
28.6 |
71.4 |
100.0 |
|
Disease groups :
In this series, we had the
largest number of cases of osteo-arthritis comprising 21.5 % ( 15 cases). There were 7 cases of
inflammation or trauma (Table II ).
Table II : Disease groups
|
Disease |
No |
Percentage |
|
Osteo-arthritis |
15 |
21.5 |
|
Cervical spondylitis |
10 |
14.3 |
|
Rheumatoid arthritis |
8 |
11.4 |
|
Sciatica |
8 |
11.4 |
|
Low back-ache |
8 |
11.4 |
|
Soft tissue inflammation |
|
|
|
Soft tissue trauma 4 |
|
|
|
Non-traumatic 3 } |
7 |
10.0 |
|
Peri arthritis of
shoulder Peri-arthritis of
shoulder 4 |
4 |
5.7 |
|
Miscellaneous conditions |
|
|
|
Painful 'heel 4 |
|
|
|
Carpal tunnel
syndrome 3 |
10 |
14.3 |
|
Olecranon bursitis 3 |
|
|
|
Total |
70 |
100 |
Other associated
conditions in some patients :
24 patients ( 34 Y. ) had
one or the other of the following conditions : Obesity ( 9 ); Diabetes ( 6 );
Hypertension ( 3 ); Bronchial asthma ( 2 ); Hyperacidity ( 2 );
IHD ( 2 ) ( Table III).
Table III : Other
associated conditions
|
Condition |
No. |
Percentage |
|
Obesity |
9 |
12.8 |
|
Diabetes |
6 |
8.5 |
|
Hypertension |
3 |
4.3 |
|
Bronchial asthma |
2 |
2.9 |
|
Hyperacidity |
2 |
2.9 |
|
Ischemic heart disease |
2 |
2.9 |
|
None |
46 |
65.7 |
|
Total |
70 |
100.0 |
Results: First
ten days of treatment X / Y capsules
At the end of first 10
days of treatment with X or Y capsules the result were as follows : There was
marked improvement during the. first 10 days of treatment in 14 cases( 40. 0% )
of the X group. In the Y group only 2 cases ( 5.7 % ) showed moderate
improvement ( Table IV ).
Table IV :
X/Y Capsules : After first 10 days of treatment
|
Result - |
X capsules |
Relief% |
Y capsules |
Relief % |
|
|
|
|
|
|
|
Excellent |
4 |
11.4 |
0 |
0 |
|
Good |
10 |
28.6 |
0 |
0 |
|
Moderate |
17 |
48.6 |
2 |
5.7 |
|
Poor |
3 |
8.6 |
4 |
411.4 |
|
Nil |
1 |
2.8 |
29 |
82.9 |
|
Total |
35 |
100 |
35 |
100 |
Results :
Second ten days of
treatment with X or Y capsules after cross-over
In the second ten days
course of treatment, those who had received X capsules before were now given Y
capsules, and all those who had received Y capsules before, were now given X
capsules. After the second ten days course of treatment, among those who
recived X capsules 13 cases ( 37.2 % ) showed marked relief and among those who
received Y capsules now, there was only marginal relief, over what was obtained
by X capsules before ( Table V ).
Results : Third ten days of treatment with X capsules only
(R. compound) N = 70.
On the whole, X capsules
gave better relief of arthritic conditions during the course of first ten days
course, and during the cross-over second ten days course of treatment. As such,
for the third ten day course of treatment, all the 70 cases were given only X
capsules, so that the patients could get further relief during the remaining
trial period ( 30 days ).
The final results after
the third and last ten days of treatment with X capsules showed that there was
satisfactory relief with X capsules in 61 cases ( 87.1 % ).
Table V : Capsules X- Y :
Results : After cross-over : Second 10 days
|
Results |
X capsules Before Relief Starting after 2nd 2nd course ten days |
% |
Y capsules Before Relief Starting after 2nd course ten days |
% |
||
|
Excellent |
0 |
5 |
14.3 |
4 |
0 |
- |
|
Good |
0 |
8 |
22.9 |
10 |
14 |
40.0 |
|
Moderate |
2 |
16 |
45.7 |
17 |
16 |
45.7 |
|
Poor |
a |
4 |
11.4 |
3 |
3 |
8.6 |
|
Nil |
29 |
2 |
5.7 |
1 |
2 |
5.7 |
|
Total |
35 |
35 |
100.0 |
35 |
35 |
100.0 |
After the trial, the
identity of X and Y capsules were revealed, and X capsules were found to be R.
Compound and Y capsules were found to be placebo ( Table VI ).
Table VI : Third ten days
of treatment with only X Capsules (R. Compound)
|
Result |
No.. of cases after 2nd course ( X + Y groups ) |
After third course |
% |
|
Excellent |
5 |
18 |
25.7 |
|
Good |
22 |
20 |
28.6 |
|
Moderate |
32 |
23 |
32.8 |
|
Poor |
7 |
6 |
8.6 |
|
Nil |
4 |
3 |
4.3 |
|
Total |
70 |
70 |
100.0 |
Discussion :
Arthritic conditions
become chronic and recurrences are frequent. The efficacy of any treatment is
judged not only by the immediate relief b-,it also on the length of intervals between
recurrences, the longer the interval of recurrence better is the drug and the
patient gets satisfied. Prolonged treatment causes side effects with many
drugs. R. Compound did not produce any side effects or toxic manifestations. Follow-up
for six months showed no recurrence.
34.3 % of patients had
associated conditions such as diabetes, hypertension, asthma, hyper
acidity, ischemic heart
disease, obesity. It was observed that there was no aggravation of the,„
conditions during the use of R. Compound or placebo, as to warrant
discontinuance of the trial.
Summary :
70 cases of different
groups of chronic arthritides were studied by double blind cross-over study,
using X capsules and Y capsules, one set containing R. Compound and the other
set containing placebo. The identity of the capsules were revealed only after
the trial was over, the trial period being 30 days. 87.1 Y. of patients showed
satisfactory response with R. Compound. In those naving associated conditions
like diabetes, hypeitension, hyperacidity etc., there was no aggravation of the
condition due to the therapy. R. Compound showed no side or toxic effects and is
found to be useful drug in chronic and recuriing arthrides conditions.
Acknowledgement :
My special thanks are due
to Dr. N. Nirmala and Dr. S. Jayalakshmi, who assisted me during this study. My
thanks are also due to Mr. P. G. Shukla of ` Manthan ' and to Alarsin Pharmaceuticils,
Bombay 400 423 for their co-operation in my trial study.
References :
1. Etnirajulu, G, and Venkata Reddy, J. : R. Compound in Rheumatoid Arthritis and other chronic
a.rthritides : 4th Annual Maharashtra Medical Journal, Vol. XXVII, No. 11, February 1981
2. A double blind cross-over trial of R. Compound -Dr. V, R. 14turly Conf. of the Assn. of
Ortho. Surgeons of A. P., Hydqrabad, July, 1972.
3. Gujral, M. L., Saraen, K., Amma Tanju, M. K. P. and Roy, A. K. : Experimental i work on ingiedients of
R. Compound, Ind. J. Phy. & Pharm. 4, 26 ( 1962 ). 'i3. Herd, C. W: and Mundy,
L. M. ( 1952)
4 . Toxicity Tests on R. Compound. Karandikar, G. K. K., Gulati, O. D. and Gokhale, S. D. : Experimental
Work on ingredients of R. Compound : Ind. Jr. Med. Res. 48, 482 ( 1960 ).
5. Makhani, J. S. ( 1974 ) : Experience witn R. Compound in Rheumatoid Arthritis : XXIX Annual Conf. o£ the
Asso. of Physicians of India, Patna, Jan. 1974 and XXXIII Annual Conf. of Asso. of Surgeons of India, Trivandrum, Jan-Feb. 1974 and The Clinician, 40, 8,
Aug. 1976, p. 212.
6 . Mohindra, Y. and Mohan, S. ( 1979 ) : R. Compound in chronic non-spe-ific Arthritis : Cur. Med. Pract.
23, 1, 1979, p. 33.
7. Patnaik, B. C. ( 1971) : Clinical trial with R. Compound in
Rheumatoid and other Arthritic disorders : Cur. Med. Pract, 15 : 2, 625, Feb.
71.
8. Pradhan, C. G. ( 1965 ) : Use of an Ayurvedic R. Compound in
Chronic orthopaedic conditions : Bombay Hosp. Jr. : 7 : 4, Oct. 1965.
9. Raghava Rio, L. V. ( 1976 ) : Clinical trial of R. Compound in
Acute soft tissue trauma. : Karnataka State Ortho. Surgeons Conf., Manipal, 14
Feb. 1976.
10. Ramachandra, K. ( 1972 ) : R. Compound in Rheumatoid Arthtitis : Mediscope XV, 6, Sept. 1972, p.
253.
11. Sandhu, R. S., Sohal Hardip Singh and Singh Tejinderjit ( 1975 )
: Clinical evaluation of R. Compound in Rheumatoid Arthritis and in certain
other orthopaedic disorders : 5th Annual Conf. of Ind. Rheumatism Assn.,
Amritsar, Dec. 1975.
12. Sardesai, H.
V. and Deshpande, S. S. (1968 ): Use o£ R. Compound in Rheumatoid Arthritis :
First Congress of SEAPALAR, Bambay, Feb. 1968.
13. Shanmugsundaram, T. K.
and Dosa, Henry ( 1973 ) : Controlled trial of R. Compound, Vth Conf. of T.
Nadu Ortho. Assn., Madras, April 1973.
14. Subramaniam, R. and
Parthasarathy, M. S. ( 1968 ) R.Compound in Rheumatic Arthritis First Congress of SEAPALAR, Bombay,
Feb. 1968.
15. Yadav, S. S. ( 1975 ) : Clinical Trial of R. Compound in
Rhuematoid Arthritis : 48th All India Ayur. Conf., Pondicherry, Feb. 1975, and
Cur. Med. Pract. 19, 11, Nov. 1975, p. 509. Maharashtra Medical
Journal, Vol. XXVII, No. Il, February 1981