Ridhambaradevi, G (2018) Preclinical and Clinical Evaluation of Baalavaatham (Paresis) With Siddha Therapeutic Management in Children. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The disease Baala Vaatham was taken for the clinical study with Chitramutti Kudineer Chooranam as internal medicine and Baala Vatha thylam as external application. For the clinical study, 30 children were selected based on the approved protocol. This study has been approved by IEC of NIS [Date of IEC Approval & its number: NIS/IEC/2016/11-22/14.10.2016]. Animal studies were carried out after obtaining approval from the Institutional Animal Ethical Committee (IAEC) Approval & its number NIS /IAEC – IV/06/05012017 and the trial was registered in Clinical Trial Registry of India CTRI/2018/04/013296) Hence the study is safely executed on children and there was no adverse drug reactions noted during the study period. The toxicological evaluations were conducted as per WHO guidelines for safety evaluation of Chitramutti Kudineer Chooranam. In acute toxicity study, no signs of toxicity and mortality were observed throughout the study. In organs of Control group, no abnormality was detected. In the necropsy normal structure present in test group of animals. 30 children, were treated with trial medicine in OPD, IPD of Department of Kuzhanthai Maruthuvam, Ayothidoss Pandithar Hospital of National Institute of Siddha, Chennai-47. The detailed study on Chitra mutti Kudineer Chooranam with reference to its aetiology, pathogenesis, clinical features, diagnosis and treatment with trial drugs were done. The children were diagnosed and included on the basis of MODIFIED ASHWORTH scale (Spasticity Assessment scale) and the results were observed by Modified Ashworth scale before and after treatment. Based on the Modified Ashworth scale – Totally 30 children were treated for Balavaatham out of them 3 children were reported with Grade 0 (No increase in muscle tone) but with features of difficulty in using the limbs, after treatment they had Grade 0 but the difficulty using the limbs was improved and they were able to walk feely. Out of the remaining 27 children 12 children reported with Grade 2 at the onset of the treatment out of them 10 (83.3%) children had which exhibits Grade 1, and 2 (16.6%) children had Grade 1+ at the end of the treatment. Which good improvement. Out of 12 children with Grade 3 at the onset of the treatment 1 (8.3%) child improved to Grade 1 and 11 (91.6%) children had improvement to Grade 1+. As there is a very good improvement after treatment as noted above it can be concluded that the drug has reduced the spasticity of the affected children. CONCLUSION: The acute Safety study conducted on the trial drug shows that the trial drug Chitra mutti kudineer Chooranam (Internal) safe for human usage. The Physiochemical analysis carried out proves the percentage of Loss on drying, Total Ash value, Acid insoluble ash, Water soluble ash, Water soluble extraction, Alcohol soluble actions. The Phytochemical analysis shows the presence of Carbohydrates, Flavonoids, Saponin, Diterpins, Quinones. The biochemical analysis shows the presence of Potassium, and Iron, Chloride, Phosphate, Alkaloids, Tannic acids. This study proved that formulation of (medicine /drug)has given good results in many children through clinical trials and it may be better solution for reducing the muscle dryness, spasticity, increasing the blood circulation, increasing the nervine strength, muscle bulk, tone, power, and reflex thereby reducing the inability or difficulty of movements in the affected limb. This has created confident in paresis children to improve their quality of life and to perform their day to day activities. It also reduces the risk of their parents and freed them from their physical and mental burden. No adverse effects were noted during the course of treatment.
| Item Type: | Thesis (Masters) |
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| Additional Information: | (Reg. No: 321514206) |
| Uncontrolled Keywords: | Preclinical and Clinical Evaluation ; Baalavaatham ; Paresis ; Siddha Therapeutic Management ; Children. |
| Subjects: | AYUSH > Kuzhanthai Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 29 Dec 2018 11:04 |
| Last Modified: | 29 Dec 2018 11:04 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10267 |
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