Efficacy of an Ayurvedic Formulation in Rheumatoid Arthritis

 

D.K. Sanghi* and S.B. Joshi

Shri Laxmanrao Mankar Institute of Pharmacy, Amgaon, Dist- Gondia (MS) India

 

ABSTRACT:

Vitex nigundo, Boswellia serrate, Curcuma longa and Tinospora cordifolia produce synergistic action in rheumatoid arthritis. The clinical efficacy of an Ayurvedic indigenous formation containing Vitex nigundo, Boswellia serrata, Curcuma longa and Tinospora cordifolia was evaluated in a randomized, double blind, placedo controlled, cross-over study in 20 patients of rheumatoid arthritis. Treatment with the indigenous formulation for the period of 3 months produced significantly greater relief of pain, decreased morning stiffness, decrease in Ritche articular index and joint score.

 

INTRODUCTION:

Rheumatoid arthritis is a common disorder with varied clinical signs and symptoms related to multiple anatomical sites, both articular and extra-articular1.

 

Presently, the non-steroidal anti– inflammatory drugs (NSAIDs) are the mainstay in this condition, however, they have serious adverse effects and have limitations for a long term therapy2,3. The immunosuppressive drugs are reserved for selected cases, while the disease modifying drugs like gold-salts are costly and have low benefit risk ratio4. Hence, there is a need for drugs having good efficacy with low toxic profile in this debilitating disorder.

 

A number of indigenous drugs have been claimed to be effective in the treatment of rheumatoid disorders; but their claims have not been largely substantiated in well controlled clinical trials. The formulation under investigation (Rheumax), is one such preparation which has been largely substantiated in well controlled clinical trials. The formulation under investigation (Rheumax), is one such preparation which has been prepared on the basis of Indian medicinal system of Ayurveda.5 The ingredients used in this formulation have been claimed to be effective in rheumatoid disorders and the efficacy in rheumatoid disorders and the efficacy of these ingredients have been evaluated in both, animal models and clinical trials. We now report the result of prospective double blind, placebo controlled trial of this indigenous formulation in the treatment of rheumatoid arthritis.

 

Materials and Methos:

Twenty patients (14 females, 6 males) attending the Rheumatology Clinic with symptoms of rheumatoid arthritis were included in this study. Their mean (SEM) age and duration of illness were 30.4 (1.8) and 2.1 (0.4) years respectively. The inclusion criteria’s were morning stiffness, joint deformity, spells of remission and exacerbation with radiological changes and serologically positive rheumatoid arthritis factor. Patients having diabetes mellitus, hypertension, peptic ulcer, renal failure, liver disorders, pregnancy, were excluded from the study.

 

Study design:

After informed consent, the patients entered into a double-blind, randomized, cross-over study of treatment with the indigenous formulation or a matching placebo in the dose of 2 capsules 8 hourly after food. Each treatment was given for a period of three months and then after a wash-out period of two weeks the patients were transferred to the other treatment limb for the final three months.

 

Assessment of Patients:

After entry into the study, the patients were evaluated weekly in a run-in period of one month during which all their previous drug therapies were withdrawn. The patients were evaluated on weekly basis using clinical parameters which included severity of pain (score), morning stiffness, Ritchie articular index, joint score (As described by the American Rheumatism Association), disability score and grip strength.6,7 Erythrocyte sedimentation rate, rheumatoid arthritis factor8 and radiological examination9 were performed every month.

 

Side effects volunteered by the patients were recorded at each visit and the patients’ compliance was assessed by asking the patient to return the capsule container and counting the remaining capsule container and counting the remaining capsules. At the end of the study period, the patients were asked to express their preference for one of the two treatments given. The patients were free to withdraw from the study if they so desired. Additional prescription of NSAIDs were allowed in case of severe pain.

 

Treatment:

The indigenous formulation based on Ayurvedic medicine was prepared from herbal materials, composition of which is given in Table 1. Botanical identification and Ayurvedic criteria for desired quality were in accordance with the guidelines of pharmacopoeia 1 standards10 and were carried out by a qualified chemist approved by Food and Drug Administration. All the herbal ingredients were powdered finely and mixed into desired quantities and hard capsules were prepared in accordance with standards guidelines.

 

Table 1. Composition of Ayurvedic formulation

Scientific name

Plant part

Each capsule contains extract from (mg)

Vitex negundo

Boswellia serrata

Curcuma longa

Tinospora cordifolia

Leaf, Stem

Oleo-gumresin

Rhizome

Stem

300

500

250

500

 

Results and Discussion:

Treatment with the indigenous formulation altered clinical and biochemical parameters significantly as compared with placebo (p<0.01) and produced greater pain relief. A significant reduction in time duration of morning stiffness, joint score and the erythrocyte sedimentation rate was observed, however the grip strength was significantly increased (Table 2). Onset of significant therapeutic effect started from the end of second week and remained till the end of the therapy. Treatment with indigenous formation produced seroconversion of rheumatoid arthritis factor in 9 patients at the end of three months period compared to none in the placebo group. The seroconversion achieved during therapy with indigenous formulation did not revert during the placebo period. Radiological assessment did not show significant change either due to drug or placebo therapy. The drug treatment group had one patient complaining nausea, one had dermatitis and four with pain in abdomen, however, these side effects did not necessitate discontinuation of drug therapy.

 

Table 2. Effect of Rheumatoid at the end of 3 months

Description

Placebo

Ayurvedic formulation

Severity of pain (score)

Morning stiffness (minutes)

Joint score

Ritche articular index

Grip strength (mm Hg)

Disability score

Erythrocyte sedimentation rate (mm/hr)

7.76±0.09

34.20± 3.69

4.17±0.35

8.86±0.56

33.07±2.70

2.13±.19

 

35.13±1.98

1.06±0.12*

17.57±2.55*

1.93±0.28*

4.96±0.49*

57.59±3.43*

0.76±0.16*

 

20.67±1.64’

Mean ± SEM, P < 0.01

 

Patient’s compliance was satisfactory in both the groups. Out of 20 patients, 18 preferred the indigenous preparation and 2 placebo (P < 0.05).

 

Analysis of data indicated that the residual effect outlasting the drug administration in case of indigenous formulation group did not remain more than two weeks. The drug treatment group had three patients and the placebo group had 18 patients who required NSAIDs to control their pain (P < 0.05).

 

DISCUSSION:

The present study indicates the clinical and biochemical efficacy of the indigenous formulation in the treatment of rheumatoid arthritis. This formulation was designed after scrutiny of the evidences given in texts of Ayurvedic medicine and available research data11. Among the contents of this plant Tinospora cordifolia commonly known as Guduchi is considered to be efficacious. Studies on induced edema and arthritis and on human arthritis proved the anti-inflammatory potency of the water extract of this plant12,13.

 

Phase I and Phase of adjuvant induced arthritis were also inhibited. The anti-inflammatory of this plant resembles that of non steroidal anti inflammatory agents13-16. Curcuma longa, commonly known as Turmeric has antiseptic and anti-inflammatory properties. Curcumin, an alkaloid isolated from this plant has anti-inflammatory, anti-arthritic and anti-rheumatic properties. It also has beneficial effect on platelet aggregation and vascular prostaglandin synthesis.

 

The activation of adrenohypophysial axis may be (Mineral) responsible for inhibition of late arthritic changes. Activated proteases which are responsible for acute inflammatory process are inhibited by the volatile oil of the plant which by the volatile oil of the plant which17-19 Boswellia serrata, commonly known as Sallai Guggul contains beta boswellic acid, a pentacyclic triterpene, present in oleo gum-resin of the plant exudate has anti- inflammatory and analgesic activity.20,21 The Ethyl acetate extract of Vitex negundo showed a significant activity against carrageenin, 5HT and bradykinin induced inflammatory oedema. It also possessed significant inhibitory effect against granuloma pouch and cotton pellent implantation through less potent than phenylbutazone and tetramethazone22,23

 

Patients with Rheumatoid arthritis were treated with the plant and encouraging results obtained24. Vitex negundo decoctions have been used in cases of sciatica, with greater success.

 

It is possible that a combined action of these ingredients may be producing a synergistic action cannot be commented at this stage, however the present study can be considered as an important step to enter into further research in order to understand more about the pathophysiology and treatment of rheumatoid arthritis.

 

ACKNOWLEDGEMENT:

The author is grateful to Mr. Anwar Siraj Daud, Director, Zim Laboratory, Nagpur and Shri. Keshavrao Mankar, Secretary, Bhawabhuti Shikshan Sanstha, Amgaon for providing needs as and when required.

 

References:

1.        Bunch TW,. O’Duff J.D. 1980; 55:161

2.        Wright V. Br Med J 1986;96:431

3.        Clive D.M., Stoff J.S. N Engl J Med1984;310:563

4.        O’Duff J.D., Stoff J.S. N Engl J Med 1984;24:373

5.         “Charak Samhita”, Translated and published by Shree Gulabkunverba Ayurvedic Society, Jamnagar, India.. 1949

6.        Madhok R. Capell H.A. “Evaluation of Drug Responses” Chapman and Hall, 1984: 149

7.        Richie D.M., Boyle J.A., Mclness JM. et al. Clinical studies with an articular index for the assessment of joint tendernss in patients with rheumatoid arthritis Quart J Med 1968; 37: 393-406.

8.        Singer J.M. Bull Rheum Dis 1973;24:762-4

9.        Larsen A., Dale K., Eck M. Acta Radiol Dis 1977; 18:481-91.

10.      Pharmacopoeia1 Standards of Ayurvedic Formulation, New Delhi, CCRAS Government of India: 1987.

11.     Sharangdhar Samhita, Translated by KK Shri Shrikanta Murthy, Choukhamba Orientia, 1984.

12.     Pendse V.K. et al., Ind J. Pharmacol, 9:221, 1977

13.     Pendse V.K. et al, Indian Drugs, Oct: 14, 1981

14.     Sisodia, P. and V. Laxminarayanan: Ind. J. Physiol. Pharmacol. 2:21, 1961

15.     Rai, M. and S.S. Gupta,: J. Physiol Pharmacol. 10-12, 1966

16.     Gulati, O.D. et. al : Rheumatism 17:76, 1982

17.     Deodhar S.D., Sathi R., Srimal R.C. Preliminary clinical study of anti-arthritic activity of Curcumin. Ind J Med Res 1902:71:632.

18.     Srimal R.C., Khanna NM, Dhavan BN. Ind J Pharmac 1971; 3:10.

19.     Ramprasad C., Sirsi M. Ind J Physiol Pharmacol 1957;1:136

20.     Menon M.K., Kar A. Planta Medica 1971;3:10

21.     Reddy G.K., Dhar SC. Ital J Biochem 1987:36:205.

22.     Sharma A.K. et al, Bull. Med. Ethnobot Res. 1:262, 1980

23.     Mohiddin, S.G. 14:97, 1974

24.     Jain, P.K. and T.N. Pande : J. Res. Ind Med. Yoga Homeo. 11:2, 1976

25.     Vischer T.R. Levamisol in rheumatoid arthritis. J Rheumatol 1978;5:49

 

Received on 23.04.2010

Accepted on 13.05.2010        

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Research Journal of Pharmacognosy  and Phytochemistry. 2(4): July-Aug. 2010, 306-308