Phase II Non Randomized Clinical study on “Neer Kana Mantham’’ (Acute Nasopharyngitis) with Evaluation of Siddha Trial Drug “Aavarai Karukku Kudineer”

Manju, S (2021) Phase II Non Randomized Clinical study on “Neer Kana Mantham’’ (Acute Nasopharyngitis) with Evaluation of Siddha Trial Drug “Aavarai Karukku Kudineer”. Masters thesis, Government Siddha Medical College, Chennai.

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The disease Neer Kana Maantham (Acute nasopharyngitis) was taken for the clinical study with the trial drug of Aavarai karukku Kudineer as internal medicine. For the clinical study, 40 patients were selected based on Inclusion and Exclusion criteria. The study is conducted after the drug being screened by the Screening Committee and the trial is also approved by the Institutional Ethical Committee (IEC). The clinical study was registered in CTRI as per the regulations. Animal studies are carried out after obtaining proper permission from the Institutional Animal Ethical Committee (IAEC). Hence the study is safely executed on human volunteer patients and there were no adverse drug reactions noted during the study period. 40 children with Neer Kana Maantham diagnosed clinically are treated in an outpatient department of Arignar Anna Govt. Hospital of Indian Medicine and Homoeopathy, Chennai. In this study, the trial participants were observed for clinical improvement with their laboratory investigations. I like to summarize this study with the following highlights. ➢ The efficacy of the trial drug Aavarai karukku kudineer were studied and observed in this study. ➢ Clinical diagnosis of Neer Kana Maantham was done on the basis of clinical features described in BalaVagadam. ➢ These drugs are easily available and the dosage is also convenient. ➢ Biochemical analysis reports reveal that chlorides and sulfates are existing in trial drugs. ➢ Results of the heavy metal analysis have clearly shown that the trial drug (AVKK) has no trace of heavy metal such as lead, arsenic, and cadmium. ➢ The results of the phytochemical analysis show the present of Steroids, phenol, protein in trial drug and alkaloids, flavonoids, glycosides, tannin, saponins, sugar were absent. ➢ Aflatoxin report indicates that the trial drug was free from Aflatoxin B1, B2, G1, and G2. ➢ The dose of AVKK used for acute toxicity study was 5000mg/kg. It was higher than the normal therapeutic dose. No mortality was observed at this dosage level, further there was no significant change with respect to clinical signs on acute toxicity observed over a period of 14 days and as same as the acute toxicity study there was no toxin noted in sub-acute study. ➢ Pharmacological analysis of the trial drug reveals that it possesses convincing Anti-microbial and Anti-inflammatory property. ➢ Among 40 cases, 32 cases (80%) had shown good improvement, 6 cases (15%) had shown Moderate improvement, 2 cases (5%) had shown Mild improvement. So, the trial drug made during the study was clinically safe, effective and has no adverse effect. CONCLUSION: Neer Kana Mantham is a common disease in children. The pre-clinical and toxicological studies proven the safety and efficacy of the trial drug Aavarai karukku kudineer in acute nasopharyngitis. The pharmacological study has proven Anti-microbial and Anti-inflammatory activity was existing in the trial drug. The trial medicine was easily available. During the clinical study, no adverse events were observed in every study participants. The clinical study confirms the efficacy of the trial drugs by reducing the clinical symptoms such as cough, cold, running nose, fever and loss of appetite. Clinical study results found to be good in 32 cases (80%), moderate in 6 cases (15%) and mild in 2 cases (5%). So the trial medicine “AAVARAI KARUKKU KUDINEER” is effective for Neer Kana Mantham (Acute nasopharyngitis) in children, age group between 3 - 12 years.

Item Type: Thesis (Masters)
Additional Information: 321814101
Uncontrolled Keywords: Neer Kana Mantham, Acute Nasopharyngitis, Evaluation, Siddha Trial Drug, Aavarai Karukku Kudineer, Phase II Non Randomized Clinical study.
Subjects: AYUSH > Kuzhanthai Maruthuvam
Depositing User: Subramani R
Date Deposited: 17 Nov 2022 15:35
Last Modified: 17 Nov 2022 15:35

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