Clinical Evaluation of Panchathikta Kirutham (Internal Medicine) and Karunkozhi Thylam (External Medicine) in the Management OF Uthiravatha Suronitham (Rheumatoid Arthritis)

This study is aimed to the therapeutic efficacy of Siddha herbo mineral formulation PANCHATHIKTA KIRUTHAM (Internal medicine) and KARUNKOZHI THYLAM (External medicine) in Uthiravatha suronitham (Rheumatoid arthritis) cases. ❖ The study protocol was prepared and submitted to the Institutional Ethical Committee (IEC) of National Institute of Siddha. The date of IEC approval and IEC number is 21.12.2020; NIS/IEC/ 2020/D-5. ❖ The trial was registered in clinical trial registry of India with the Registration no: CTRI/2021/09/036341[Registered on: 08/09/2021]. ❖ The raw drugs were authenticated by the Botanist, National Institute of Siddha, Chennai 600047. ❖ The Siddha Herbo mineral formulation Panchathikta kirutham (Internal medicine) and Karunkozhi thylam (External medicine) were prepared as per the standard operating procedure mentioned in Siddha literature in the Gunapadam laboratory, National Institute of Siddha under the guide's supervision. The biochemical analysis was done in Biochemistry Lab, NIS, Tambaram Sanatorium, Chennai -600047. ❖ The biochemical analysis showed that the presence of Carbonate, Iron, Calcium, Lead, Zinc, Magnesium, Starch and alkaloid in Panchathikta kirutham Physiochemical, Phytochemical, HPTLC, Heavy metal analysis, Pesticide , aflatoxin analysis of the trial drug have been carried out in Noble Research Solution Pvt., Ltd., ❖ Physiochemical analysis of Panchathikta kirutham was carried out for each extract of Panchathikta kirutham Viscosity at 50oC (Pa s) 61.95, Refractive index1.32, Weight per ml (gm/ml) 1.18, Iodoine value (mg I2/g) 90.17, Saponification value (mg of KOH to saponify 1gm of fat) 197.39, Acid Value mg KOH/g 1.17, Peroxidase Value mEq/kg 5.8. ❖ The phytochemical analysis showed the presence of Steroids, Triterpenoids, Coumarin, and Protein. ❖ The result showed that there were no traces of pesticides residues such as Orgnochlorine pesticides, Organophosphorus pesticides, Organo carbamates, Pyrethroids. Hence it should be BDL as in the above analysis. ❖ Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2 were absent in aflatoxin analysis of Panchathikta kirutham. ❖ HPTLC finger printing analysis of the sample revealed that the presence of four prominent peaks corresponds to the presence of four versatile phytocomponents present within it. Rf value of the peaks ranges from 0.02 to 0.83. ❖ Clearly showed that the sample has no traces of heavy metals such as Arsenic, Mercury and Cadmium, where as the sample showed the presence of Lead at 0.14 ppm. Which level was below the prescribed limit. ❖ Specific pathogen such as E.coli, Salmonella, Staphylococcus Aureus, Pseudomonas Aeruginosa were absent in Panchathikta kirutham. These parameters are essential for the safety of the drug from microbial contamination for human consumption. ❖ No growth/ colonies were observed in any of the plates inoculates in the test drug. ❖ For the clinical study, 60 cases were screened based on inclusion and exclusion criteria at the OPD of Maruthuvam, NIS. Out of 60 cases, 30 cases were recruited for the clinical trial. Both Siddha and modern methodology used for clinical diagnosis of Uthiravatha suronitham. ❖ Before initiating the clinical trial, informed consent was obtained from all the patients. ❖ All the patients were advised for Day 1 purgation with Agasthiyar kuzhambu (130 mg) with Inji rasam (5ml) and oil bath with Arakkuthylam on Day-2, Day-3 patients were advised to take rest, no medicine was given on the day to correct the elevated mukkutram. ❖ Day -4th onward the trial drugs Panchathikta kirutham - kaal palam (8.5 g) were administrated orally after food twice a day and Karunkozhi thylam was applied over the affected joints. The trial drugs were given for 45 days in all recruited Uthiravatha suronitham cases. Clinical assessment had been done during each visit in OPD patients (7 days once) and the data were noted in the Case Report Form. ❖ Routine Hematological, Biochemistry, urine examination had been done before and after treatment. ❖ The prognosis was recorded through Universal pain scale and Gradation movement scale and clinical symptoms on the initial day and 49th day. ❖ Diet restriction was strictly followed during the trial period as well as in the re dieting period, as noted in the dietary advice form. ❖ In the clinical trial there was no adverse drug reaction noted during the treatment period. ❖ Based on EULAR criteria, before treatment positive EULAR score for 100% of cases, after treatment it was negative in 56.6% of cases. There is a significant reduction of EULAR score before and after treatment. (p<0.000). ❖ Based on UNIVERSAL PAIN SCALE, Out of 30 cases, before treatment 9 (30%) of cases had severe pain, 66.6% of cases had moderate pain, 1(3.3%) of case had mild pain in all minor and major joints. ❖ After treatment, pain completely reduced in 5 (16.6%) cases, 21 (70%) cases had mild pain and 4 (13.3%) cases had moderate pain. There is a significant reduction of pain with the trial drug. (p<0.000). ❖ Before and after treatment clinical symptoms have been significantly reduced. (p<0.000). ❖ Based on RESTRICTED MOVEMENT ASSESSMENT SCALE, Out of 30 cases, before treatment 2 (6.6%) cases were presented in Grade IV due to severe pain, 25 (83.3%) cases were presented in Grade III due to moderate restricted movements, 3 (10%) cases were presented in Grade II due to mild restricted movements. ❖ After treatment 7 (23.3%) cases were in Grade I, 22 (73.3%) cases were presented in Grade II, 1 (3.3%) case was presented in Grade III. There has been a significant improvement in the movement of joints in the trial drug. (p<0.000). ❖ Based on ESR, Among the 30 cases, before treatment ESR increased in 28 (93.3%) cases and 2 (6.6%) cases had normal ESR values. ❖ After treatment in 20 (70%) cases ESR reduced, 10 (30%) cases had Normal ESR values. There has been a significant reduction in ESR value after treatment. This in turn results in the control of the inflammatory process of the disease. (p<0.000). ❖ Based on CRP Among the 30 cases, before treatment CRP was positive in 25 (83.3%) cases and negative in 5 (16.6%) cases. ❖ After treatment CRP was negative in 14 (46.6%) cases, reduced in 12 (40%) cases and increased in 4 (13.3%) of the cases. There has been a significant reduction in CRP value after treatment. (p<0.000). ❖ Before treatment, Rheumatoid factor positive in 90% of cases and 10% of cases had negative. After treatment, Rheumatoid factor was Negative in 36.6% of cases, reduced in 40% of cases and increased in 23% of cases. There is no significant change. (p<0.21). ❖ Before treatment, ASO titer was positive 16.6% of cases, after treatment It was positive in 6.6% of cases. There is no significant change. (p<0.07). CONCLUSION: All the results of the clinical study showed that the trial drugs are very effective in lowering the symptoms of Rheumatoid arthritis and the laboratory parameters ESR, CRP, RA factor, Anti CCP within the treatment period of 45 days. ❖ Based on statistical analysis, before and after treatment the clinical symptoms have been significantly reduced. (p<0.000). ❖ Based on statistical analysis before and after treatment the Universal pain scale, Gradation movement assessment scale and Lab investigations have been significantly reduced in all cases.(p