Indian Journal Of Traditional Knowledge
Vol. 8(3), July 2009, pp. 446-448

Study on efficacy of Siddha drugs (CL and CEN) in rheumatoid arthritis

B Muthukumar

Central Council for Research in Ayurveda and Siddha, 61-65, Institutional area, Opposite D- Block, Janak Puri, Delhi 110 058

E-mail: muthu_siddha@yahoo.co.in

Received 2 April 2008; revised 4 February 2009

Siddha system, a traditional Indian Systems of Medicine, noticed much of the musculo-skeletal disorders, termed as Vatha diseases, under which joint diseases were put as Keel vayu. Vali azhal keelvayu is one among the types of keel vayu. In ancient Siddha texts, various causative factors, clinical features as well as the treatment methodology for the disease vali azhal keelvayu were broadly explained. This condition was well correlated with the disease rheumatoid arthritis, for which there is no curative drugs. So, two polyherbal Siddha drugs (for internal and external use), were tried in a clinical trial as well as pharmacological, biochemical analysis in order to prove the efficacy of these drugs in rheumatoid arthritis, which revealed a positive answer.

Keywords: rheumatoid arthritis, Siddha drugs

IPC Int. Cl.8: A61K36/00, A61P19/00, A61P19/02, A61P29/00

 


Rheumatoid arthritis (RA) is a chronic multi-system disease that affects joints connective tissue, muscles, tendon and fibrous tissue, which is basically an inflammatory joint disease, primarily characterized by a symmetrical, poly arthritis affecting 3% of total population in 25 -50 yrs of age. Females are more affected than males (3:1). Generally considered as systemic disease, but in early stages it is only an articular disease characterized by inflammation, edema of synovium with increased vascularisation and pannus formation. This is followed by destruction of cartilage by pannus, distension of joint capsule, destruction of bony joint margin and sub chondral bone leading to joint damage resulting in deformity, fibrous ankylosis and eventual bony ankylosis of joints. There is not a total curative therapy for the disease. The disease mentioned in Siddha literature as Vali azhal keelvayu and a study about the efficacy of polyherbal Siddha drugs, i.e CL (internal), C EN (External) on rheumatoid arthritis was carried out by conducting a clinical trial as well as pharmacological and biochemical analysis carried out at Government Siddha Medical College, Palayamkottai, Tamil Nadu during 2002-2004 at PG Department of Special Medicine1.

 

Methodology

For the clinical study 20 patients suffering from rheumatoid arthritis were selected by adopting a criterion as  laid down by  American   Rheumatologist

Association. The Criteria for inclusion were morning stiffness of minimum 1 hr duration, arthritis of 3 or more joints, arthritis of hand joints, symmetric arthritis, rheumatoid nodules, serum rheumatoid factor, and radiological changes pertaining to rheumatoid arthritis. Patients with four or more of the above features were included for the clinical trial. Exclusion criteria included CVS: pericarditis, myocarditis, endocarditis, valvular heart diseases; RS: pleurisy, pleural effusion, interstitial fibrosis, rheumatoid arthritis nodules, bronchiolitis; GIT: severe acid peptic disease, H/o GIT bleeding; renal: amyloidosis, renal tubular acidosis, renal insufficiency- drug induced; neurological : Nerve entrapment syndrome like Carpal tunnel syndrome; eye : Keratoconjuntivitis, scleritis, episclertis; deformities: joints with permanent deformities; surgical : those underwent orthopaedic surgeries on the affected joints; and pregnant and lactating women. Selected 20 cases (Male 11, Female 9) at varied age group were admitted as in patients at Govwernment Siddha Medical College Hospital, Palayamkottai for about 3-7 weeks (Tables 1-2). After necessary ethical clearances and written consent, patients were enrolled for treatment. All the 20 cases were subjected to the following investigations: blood (routine tests – TC, DC, ESR, Hb, sugar, urea and total cholesterol, and rheumatoid arthritis factor); urine (routine albumin, sugar, deposits, bile salts, and bile pigments); radiology  (X- ray of the affected joints). The selected

Table 1¾ Case history charts (Age distribution)

Age (in yrs)

No of cases

%

21-30

2

10%

31-40

4

20%

41-50

3

15%

51-60

7

35%

61 and above

4

20%

Total

20

100%

Table 2¾ Sex distribution

Sex

No of cases (out of 20)

%

Male

11

55%

Female

9

45%

Total

20

100%

Table 3¾ Case history chart

 

In-Patient

No

WBC Total Count Cu. mm

WBC Differential  Count

ESR

ESR

Hb  %

URINE ANALYSIS

P%

L%

E%

P%

L%

E%

½ hR

1 hr

½hR

1 hr

Alb

Sug

Dep

Alb

Sug

Dep

Xray

 

BT

AT

BT

AT

BT

AT

BT

AT

BT

AT

777

7200

7400

55

40

5

53

43

4

30

55

12

24

88

90

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

871

9000

9100

60

36

4

58

30

4

14

28

7

15

72

86

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

992

8200

8800

63

33

4

60

36

4

15

30

8

18

65

84

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1142

9000

9200

58

40

2

60

38

2

8

20

6

14

70

81

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1173

9600

9700

58

24

8

59

23

8

15

35

4

18

72

86

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1176

9800

9400

54

40

6

55

38

7

6

12

4

10

70

85

NIL

NIL

1-2PC

NIL

NIL

NIL

RA

 

1177

8200

8400

70

26

4

65

31

4

40

70

18

34

72

80

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1198

8500

8700

62

32

6

62

32

6

24

46

8

21

74

89

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1257

9500

9100

58

30

12

62

29

9

07

15

5

12

74

86

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1302

9200

8700

64

28

8

65

29

6

30

60

12

20

72

87

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1314

7200

8100

60

38

2

61

30

9

30

70

10

18

60

83

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1370

8600

8700

70

25

5

64

31

5

20

45

10

22

54

80

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1402

8400

8100

58

38

4

60

38

2

24

36

8

16

72

80

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1472

9000

8300

54

38

8

50

44

6

30

60

10

22

78

80

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1434

8200

8400

64

34

2

60

38

2

28

54

12

20

74

79

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1505

9000

8900

65

30

5

62

37

1

8

15

4

8

57

80

NIL

NIL

1-2EC

NIL

NIL

NIL

RA

 

1548

8600

8800

54

40

6

59

34

7

55

100

20

40

72

74

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1555

9200

8100

55

40

5

53

42

5

25

47

8

14

70

79

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1609

9200

7800

64

28

8

60

32

8

15

25

4

10

72

81

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

1624

6500

7100

60

38

2

58

40

2

50

100

14

28

68

88

NIL

NIL

NIL

NIL

NIL

NIL

RA

 

20 cases were given with polyherbal Siddha drugs: CL - 5 gm bid (internal) and CEN (external). As per the investigation results, all the cases had positive RA factor, Low Hb, increased ESR and radiological changes pertaining to RA in the affected joints before treatment. After the therapy with trial drugs, lab investigation was repeated.

 

Results and discussion

Positive markers for an effective drug in RA, i.e reduction of ESR was achieved in 16 cases (80%), increase in Hb% was achieved in 18 cases (90%), reduction in soft tissue swelling of X-ray was achieved in 14 cases (70%), and relief from clinical signs and symptoms was achieved in 17 cases (85%). Observation made during the study showed that the trial medicines were clinically effective in RA (Tables 3-4). Further, the potency of the drugs were studied by pharmacological, and biochemical analysis of the drugs. Biochemical analysis of the internal drug CL revealed that it has Ca, ferrous ion, unsaturated compound, reducing sugar in trace amount and amino acids. Pharmacological study revealed that the trial drugs have acute antiinflammatory, antipyretic, and analgesic activities.

Table 4¾ Case history chart

In –patient No

Age & sex

Date of
admission

Date of
discharge

No of days treated

Drugs given

Investigation
blood sugar mg% (PP)

Serum
cholesterol mg%

Blood

urea mg%

RA
factor

777

55/M

17.04.2003

25.02.2003

35

CLL 5mg bid
 (Int) CEN(Ext)

120

194

31

Positive

871

45/M

28.04.2003

15.05.2003

17

-do-

130

174

34

-do-

992

41/M

13.05.2003

21.06.2003

39

-do-

124

182

27

-do-

1142

70/M

03.06.2003

16.06.2003

13

-do-

142

198

36

-do-

1173

75/M

07.06.2003

20.06.2003

13

-do-

146

204

33

-do-

1176

62/M

09.06.2003

08.07.2003

29

-do-

128

178

37

-do-

1177

52/M

09.06.2003

24.07.2003

45

-do-

110

198

17

-do-

1198

60/F

11.06.2003

05.07.2003

24

-do-

148

210

27

-do-

1257

60/M

17.06.2003

11.07.2003

24

-do-

110

178

23

-do-

1302

40/F

20.06.2003

02.08.2003

43

-do-

140

168

17

-do-

1314

49/F

23.06.2003

20.07.2003

27

-do-

130

202

37

-do-

1370

25/M

30.06.2003

05.08.2003

37

-do-

142

186

31

-do-

1402

55/F

03.07.2003

21.07.2003

18

-do-

136

190

29

-do-

1472

57/F

07.07.2003

23.07.2003

16

-do-

144

204

34

-do-

1434

35/F

07.08.2003

20.07.2003

12

-do-

134

173

33

-do-

1505

60/F

17.07.2003

26.08.2003

40

-do-

120

188

29

-do-

1548

40/F

21.07.2003

25.08.2003

35

-do-

120

174

20

-do-

1555

65/M

22.07.2003

04.08.2003

13

-do-

130

183

27

-do-

1609

33/F

28.07.2003

02.08.2003

05

-do-

128

198

34

-do-

1624

25/F

30.07.2003

27.08.2003

29

-do-

130

168

17

-do-

Conclusion

From the clinical trial study, efficacy results were found good in 85% of cases. No adverse effects were noticed during the treatment period. Further follow up of the cases showed good recovery and fine improvement in the general well being as they could carry out their day to day activities. The trial drugs have acute antiinflammatory, antipyretic, and analgesic actions. Preparation of both the polyherbal Siddha drugs is simple. The treatment with the trial drugs for rheumatoid arthritis was found to be effective.

 

References

    1      Thiagarajan R, Yugu Munivar Vaithiya Chinthamani, 2nd edn, (Palani Thandayuthapani Devasthanam Publications, Directorate of Indian Systems of Medicine, Chennai), 1976.

    2      Kuppusamy Mudaliyar K N, Siddha Maruthuvam, (Tamilnadu Siddha Medical Board Publication, Chennai), 1987, 595-615.

    3      Utthamaraayan K S, Siddha Maruthuvaanga Churukkam, (Tamilnadu Siddha Scientific Development Board Publication, Chennai), 1983, 290-316.

    4      Seethaaraam Prasaath J, Anubhava Vaithiya Deva Ragasiyam, (Rathina Naicker & Sons Publication, Chennai), 1991, 157.

    5      Sambasivam Pillai T V, Tamil –English Dictionary of Medicine, Chemistry, Botany and Allied Sciences, (The Research Institute of Siddhar’s Science, Madras), 1931.

    6      Kandaswamy Pillai N, History of Siddha Medicine, (Department of Indian Medicine & Homoeopathy, Chennai), 1998.

    7      S V Subramanian & V R Madhavan, Heritage of the Tamils: Siddha medicine, (International Institute of Tamil Studies, Chennai), 1983.

    8      Veeraperumaal Pillai, S Nam Naattu Vaithiyam, (Shanmugaananthaa Book Publishers, Chennai), 2000, 384.

    9      Vaasu Deva Saastri K, Sarabenthirar Vatha Roga Sikitchai, (Tanjore Sarawathi Mahaal Publication, Tanjore), 1989, 2.

 10      Rastogi Ram P  S & Mehrotra B N, Compendium Indian Medicinal Plants, Vol. 1-3, (Central Drug Research Institute & Publications & Information Directorate, New Delhi), 1960-1989.

 11      Chatterjee A & Pakrashi S C, The treatise on Indian medicinal plants, (Publications & Information Directorate, New Delhi), 1995.

 12      Yoganarasimhan S N, Medicinal plants of India – Tamil Nadu, Vol. I-II, 2000.

 13      Satoskar R S & Bhandarkar S D, Pharmacolgy and Pharmaco therapeutics, (BombayPopular Prakasam Publications, Mumbai), 1977, 130-146.

 14      Ramzi S Cotran, Vinay Kumar & Stanley L Robbins, Robbin’s Pathologic Basis of Disease, (W B Saunders Company), 1989, 1349-1354.

 15      Lee Goldman, J Claude Bennett, Dennis Ausiello, Dennis Ausiello & Russell L. Cecil, Cecil Textbook o f Medicine, I, (Publisher: Elsevier Science), 2003

 16      Anthony S Fauci, Eugene Braunwald, Dennis L Kasper, Stephen L Hauser, Dan L Longo, J Larry Jameson & Joseph Loscalzo, Harrison’s Principles of Internal Medicine, 17th edn, (McGraw-hill Professional), 2008.

 17      Kulkarni G S, Textbook of orthopedics and trauma, (Jaypee Brothers Medical Publishers (P) Ltd, New Delhi), 2008.

 18      Natarajan M & Mayil Vahanan Natarajan, Orthopaedics and Traumatology, (All Indian Publishers, Chennai), 2003, 65.

 19      Sureshan Sivananthan & Eugene Sherry, Christopher Mow, Mercer’s Textbook of Orthopaedics and Trauma, (Hodder Education, United Kingdom), 2009.

 20      Graham Apley, A system of orthopaedics and fractures, (Buttwerworths, London), 1977.

 21      John Crawford Adams, Outline of orthopaedics, (Journal of Bone and Joint Surgery, UK), 2001.