Evaluation of Parangipattai chooranam (Internal) and Annabedhi chenduram (External) was done after getting approved by IEC of National Institute of Siddha. [IEC No: NIS/IEC/2016/11-24/14.10.2016] and the trial is registered in Clinical trial Registry of India with Reg.No.CTRI/2017/06/008755 [Registered on: 05/06/2017].
• The raw drugs of Parangipattai chooranam and Annabedhi chenduram were identified and authentication certificate was obtained.
• The drug Parangipattai choornam was a fine powder pale milky white in colour with mild odour, bitter and slightly sweet in taste.
• The drug size has a particlesize with the range of lowest 41.1 μm to highest 211.341.1 μm. The loss on drying indicates the moisture content of the drug was determined as 8.5 ± 2.8%. The total ash was found to be 0.55 ± 0.05% which indicates the inorganic content of the drug. The water soluble ash was calculated as 7.46 ± 0.72% and the value of acid insoluble ash was found to be 0.32 ± 0.15% which indicates that the drug contains negligible amount of siliceous matter. The water soluble extractive value and alcohol soluble extractive value were found to be 25.86 ± 0.81% and 34.44 ± 2.12%. The pH value is measured as 4.8 which indicate that the drug is acidic.
• HPTLC was done to identify phyto- chemicals and their Rf values were calculated.
• The drug is free of microbial contamination and pesticide residues.
• In heavy metals analysis mercury was not detected and lead, arsenic, cadmium were present within the permissible limit.
• Aflatoxin like B2, G1, G2 were not detected except B1 which was within the permissible limit.
• The disease Venpulli was taken for the clinical study with Parangipattai chooranam (Internal) and Annabedhi chenduram (External) as a trial medicine and 30 cases were selected based on the approved protocol.
• The detailed study of Venpulli with reference to its etiology, pathogenesis, investigations, clinical features, diagnosis and treatment with trial drug was done.
• The results were observed by VASI score. Among the 30 cases treated 57% of the cases had moderate improvement and 43% had pigmented spots in depigmented area.
• Statistical analysis: The Mean Standard Deviation of VASI Score before and after treatment was 5.58 ± 5.4 and 4.89 ± 5.36 respectively which is statistically significant (p < 0.001).
• The analysis reveals that there is 12% reduction in depigmentation when compared to before treatment.
CONCLUSION:
The poly herbal formulation Parangipattai chooranam (Internal) and Annabedhi chenduram (External)exhibited no toxicity on short term administration in children. The present clinical study confirms the efficacy and safety of the trial drug ―Parangipattai chooranam (Internal) and Annabedhi chenduram (External)‖ which is Siddha poly herbal and herbomineral formulation respectively.
• It was found to be having good result on Venpulli patients in reducing clinical symptoms like depigmention of skin.
• The Mean Standard Deviation of VASI Score before and after treatment was 5.58 ±5.4 and 4.89 ± 5.36 respectively which is statistically significant (p < 0.001). The analysis reveals that there is 12% reduction in depigmentation when compared to before treatment.
• The qualitative outcome shows that 100% of the cases had pigmentation in depigmented area and good improvement in 57%.
• From the above results, the trial drug ―Parangipattai chooranam (Internal) and Annabedhi chenduram (External)‖ provides moderate improvement in the treatment of Venpulli.
• The open clinical trial conducted on Venpulli with the trial drug Parangipattai chooranam (Internal) and Annabedhi chenduram (External) creates a very good impact on the pigmentation of the affected area. Hence the author recommends by increasing the trial period for about 90 days will bring out the tremendous effect of the drug in future which will reduce the stress of the affected children and enable to lead a healthy life.
• As a conclusion it can be stated that the Siddha Herbal formulation Parangipattai chooranam (Internal) and Annabedhi chenduram (External) can be used as a safe and extremely efficacious drug towards the management of Venpulli in children which takes a huge toll of inducing psychological stress and impact on the cosmetic purposes