Nalini Sofia, H (2016) Evaluation of Safety and Efficacy of Nandukkal Parpam in the treatment of Kalladaippu (Urolithiasis). Doctoral thesis, National Institute of Siddha, Chennai.
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Abstract
OBJECTIVE: The objective of the study is to evaluate the safety profile of the trial drug in animal model as per WHO guideline, and efficacy profile in conducting clinical trial in Kalladaippu (Urolithiasis) patients according to Good clinical practice guidelines. MATERIALS AND METHODS: The test sample Nandukkal parpam was purchased from the Indian medical practitioners’ co-operation pharmacy and stores Ltd. Chennai. Organoleptic characters (colour, appearance, odour, taste, touch), different quantitative parameters such as pH, ash (% w / w), acid insoluble ash (% w / w), loss on drying @ 105 ͦ C, water soluble extractive, alcohol soluble extractive, calcium content and foreign matter were tested according to the prescribed standard methods in Captain Srinivasa murti Research Institute of Ayurveda and Siddha Drug Development, Arumbakkam, Chennai 106. Qualitative analysis was carried out in Biochemistry laboratory, National Institute of Siddha, Chennai -47. The particle size distribution of the test drug was estimated through Scanning electron microscope Analysis (SEM). Energy Dispersive X-Ray Analysis (EDAX) technique was applied to identify the elemental composition of materials in Nandukkal parpam. For the safety concern the acute and long term toxicity study in animal model was carried out according to the WHO Guideline “Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines”. Acute toxicity study: The animals were divided into 2 groups with 10 mice (5 males and 5 females) in each group. The animals were fasted overnight before the administration of test drug. Group I served as the vehicle control and Group II served as the toxic dose. The vehicle control group was given sirupeelai kudineer 1ml and the treatment group received nandukkal parpam at a Single dose of 9.36 mg / kg. bodyweight through oral gavage. After administration of the test drug Observations were made and recorded systematically and continuously as per the guideline. Long term toxicity study: The both sexes of Wistar Albino rats were randomized into four groups of ten animals each (5 males, 5 females). Group I received a vehicle (sirupeelai kudineer 1ml) and served as control. Group II, III and IV served as low, intermittent and high dose of NKP respectively. All the test substances were administered daily through oral gavage for180 days. Effect on physiological functions, haematology, clinical chemistry, pathology and histopathology were analysed. Clinical trial: 122 subjects were recruited to participate in this trial by using the screening form, and the clinical trial was conducted according to Good clinical practice guideline. Therapeutic efficacy of the test substance was estimated by administering of Nandukkal parpam - 260 mg with Sirupeelai kudineer – 50 ml twice daily after food for 60 days. Clinical assessment of Abdominal Pain, Loin to groin pain, abdominal discomfort, Urethral Pain, Agonizing Pain, Dysuria, Oliguria, Burning micturition, Yellow Urine, Nausea &Vomiting, Haematuria were assessed and recorded in the CRF of each subjects in every visit during this trial. Laboratory investigations including haematological and biochemical parameters and USG-KUB were carried out before study and at the end of the study. Recurrence of stone formation, life style modifications, Climatic changes, and kidney stone associated with obesity were also analysed. RESULTS: Qualitative analysis of the formulation revealed that Nandukkal parpam possesses the elements of chlorides, phosphate, carbonate, silicate, iron and calcium. The minimum particle size obtained in this analytical study (SEM) was 500 nm at high magnification of 70,000X. There were no behavioural changes observed in single dose administration up to the maximum tolerated dose of 9.36mg/kg.b.wt.There were no treatment related histopathological abnormalities in any of the organs were noticed in long term toxicity study. There was a significant reduction in stone size (***P<0.0001), number of stone and Hydrouretero nephrosis. Clinical symptoms were relieved significantly at the end of the study (***P ˂0.0001). There were no adverse events reported during the study and there was no recurrence during the follow up period of up to one year. CONCLUSION: This study has been concluded that the trial drug Nandukkal parpam is cost effective, safe to repeated administration in kidney stone patients for a period between one to six months and it has a potent therapeutic efficacy on the management of kalladaippu. There were no adverse events reported during the study and there was no recurrence during the follow up period of up to one year.
| Item Type: | Thesis (Doctoral) |
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| Uncontrolled Keywords: | safety and Efficacy, Nandukkal Parpam, Kalladaippu (Urolithiasis). |
| Subjects: | AYUSH > Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 14 Jan 2020 17:30 |
| Last Modified: | 15 Oct 2022 02:46 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/11836 |
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