Bakkiyadevi, M (2018) Pre Clinical and Clinical Evaluation of Karappan Nei (Internal and External Medicine) in the treatment of Bala Karappan in Children. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The disease Bala Karappan was taken for the clinical study with the trial drug Karappan Nei (Internal and External Medicine) after scrutinizing by the Screening committee of National Institute of Siddha. Clinical studies were carried out after obtaining proper approval from IEC of National Institute of Siddha and the trial was registered in Clinical trial registry of India. The medicines were prepared after obtaining proper authentication of ingredients from Medicinal Botanist of National Institute of Siddha. Acute toxicity study, Physiochemical analysis, Phytochemical analysis and Pharmacological activity (anti – inflammatory) for the trial medicine was performed. All the 30 patients were treated in OPD of Kuzhandhai Maruthuvam department at Ayothidoss Pandithar Hospital of National Institute of Siddha. The patients with Bala Karappan were recruited for this study based on Inclusion and Exclusion criteria and a detailed clinical study was done. Separate proforma was maintained for each patient along with SCORAD index chart on 0, 16th, 32th, 48th day to monitor the prognosis. From the clinical study, it was inferred that Bala Karappan was affecting in the school going children (6-12 years) and the incidence was chronic in maximum number of patients. The trial drug was given two times in a day for 48 days. All the patients were advised to follow the strict diet regimen during the treatment. The Bio chemical analysis of drug showed presence of Carbonate, Iron, Starch. The physicochemical analysis showed that the trial drug was in appropriate in consistency for this study. The phytochemical analysis of drug showed presence of Alkaloids, Flavonoids, Glycosides, Steroids, Triterpenoids, Coumarins, Phenol, Tannins. The patients have not complained of any adverse effects or difficulties during the course of treatment. Thus the drug compliance was good with the patients of Bala Karappan. The clinical efficacy of the trial drugs in children was analyzed statistically with all the symptoms mentioned in the assessment criteria and also through SCROAD index value. The result were observed as follows, Among 30 children, the symptoms of Bala Karappan like 80.0% Itching, 96.7% Papules, Vesicles, Blisters, Pustules, 46.7% Pain in lower extremities, 63.3% Ulcer formation with oozing, 93.3% sleep disturbances, 30.0% hyper pigmentation were improved clinically. The signs and symptoms were reduced markedly in 30 cases by SCORAD value range of 75% -100%, and No cases have been identified the by SCORAD value range of 0%, <25% and 25% -50%, 50%-75%. The mean and standard deviation of clinical symptoms of SCORAD index value for all the 30 patients before and after treatment is 50.293 ±9.923 and 4.876 ±3.417 respectively. The mean + S.D before and after treatment on SCORAD reveals that there is reduction of symptoms in after treatment i.e 90% reduction. It is statistically highly significant in reduction of eczema. The observation made during the study both clinically and statistically explores that the trail drug Karappan Nei was effective in the management of Bala Karappan in children. CONCLUSION: All the 30 patients clinically diagnosed as Bala Karappan were treated with Karappan Nei with the of dose for 5-10 ml Internally and also used as External medicine for two times a day for 48 days. The efficacy of the trial drug for the management of Bala Karappan was significantly effective by means of SCORAD value. The reduction of clinical symptoms was highly significant (p < 0.001). The reduction in the clinical symptoms was 90% after treatment. Pharmacological activity of Karappan Nei was showed that, the drug was having potent anti-inflammatory activity by In-vitro studies. Hence the author strongly recommends that this trial drug Karappan Nei may be given to children without any hesitations for the management of Bala Karappan. The ingredients of the trial drug also cost effective. Further research works may be carried out in the large group of patients to explore this novel drug more scientifically.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Pre Clinical and Clinical Evaluation ; Karappan Nei ;Internal Medicine ; External Medicine treatment ; Bala Karappan ; Children. |
| Subjects: | AYUSH > Kuzhanthai Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 29 Dec 2018 11:06 |
| Last Modified: | 29 Dec 2018 11:06 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10263 |
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