An open clinical trial of siddha drug Akkini Chooranam (Internally) and Veera Mezhugu (Externally) in the treatment of "Kuthikaal Vaatham” (Plantar Fasciitis)
The Protocol of this study has been submitted to IEC of NIS on 26-8-2015 and then approval was got from IEC for conducting this clinical study. The IEC NO is NIS/IEC/9/2014-15/13. This study was registered in Clinical Trial Registry of India and the registration number of the Trial is CTRI/2017/06/008931. The 40 cases of Kuthikaal Vaatham were Screened and diagnosed clinically and treated in Outpatient and In-patient Department of Sirappu Maruthuvam in Ayothidoss Pandithar Hospital attached to National Institute of Siddha, Tamabaram Sanatorium and Chennai – 47. The various Siddha methods of examination of the disease were carried out and the data were recorded in the prescribed Proforma for the 40 selected cases. The day before starting treatment purgation was given with Meganatha Kuligai-2 pills in hot water at early morning. From the first day onwards Akkini Chooranam 1.5gm (twice a day) along with hotwater was given internally and Veeramezhugu (Q.S) for external use were given to the patients. During the period of treatment all the patients were put under Pathiyam (specific dietary regimen chat for the disease given to each patient. Laboratory investigations were done periodically for all the cases before and after treatment and radiological investigations were done for all the cases before treatment. The observations made during the clinical study showed that internal and external drugs were effective in relieving the pain in Kuthikaal vaatham patients. During the study period, there was no adverse event reported. As per the Siddha Literature and recent research articles, the ingredients of the trial drugs was found to have anti inflammatory, Immunomodulator, Anti- oxidant, Analgesic properties owing to the disease manifestations. Phytochemical analysis which indicates the presence of tannic acid, calcium, chloride has a role in strengthening the bone matrix. Based on the statistical significance, it was observed by the pain scale there is a reduction of heel pain reduced from 7.3±1.48 to 1.48±2.52 mean value with significant P value of <0.0001.
Hence the trial medicine may effective for Kuthikaal Vaatham. Statistical analysis showed significant reduction in the pain score before and after treatment. The outcome of the trial medicine assessed by pain scale and the results were as follows: Good improvement - 27 patients (67.5%), Moderate improvement - 6 patients (15%), Mild improvement - 4 patients (10%), No improvement - 3 patients (7.5%).
CONCLUSION:
The clinical trial proves the efficacy of the trail drugs by reducing the clinical signs and symptoms like heel pain, early morning pain, restricted movements and provides better improvement. The study results show that 3 (7.5%) of them had no improvement, 4 (10%) of them had mild improvement, 6 (15%) of them had moderate improvement and 27 (67.5%) of them had good improvement. Hence these results revealed good relief from the disease after treatment. The trial Medicines were prepared from easily available ingredients and the palatability of medicine is better and the dosage is also convenient. In this study, there was no adverse effects were reported in clinical trial. Hence the trial drugs were proven for their safety. The clinical trial conducted in selected patients was satisfactory encouraging. Further studies may be taken up to establish the efficacy of the drugs
