Project

" Evaluation of safety and efficacy of Nandukal parpam in Kalladaippu(Urolithiasis)"

Goal: This study consists of pre clinical and clinical evaluation of Nandukkal parpam. The pre clinical study included physico chemical analysis, Scanning electron microscope Analysis (SEM), Energy Dispersive X-Ray Analysis (EDAX), and Toxicity study of the test drug.Clinical study included pilot study and clinical trial as per GCP.

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H.Nalini Sofia
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This is the electronic document designed to record all of the protocol required information to be analyzed after study on each trial subject. All the source data related to the study of each trial subjects were maintained with a separate Trial master file (TMF). Before administering the first dose of the test drug, all the baseline data, required laboratory data including USG - KUB, data relevant to Siddha system, clinical outcome data were recorded in this Case Report Form of each trial subject. At each visit -clinical assessment, Enn vagai thervu, any AE / SAE, any other concomitant medication were recorded in the CRF. At the end of the study, clinical assessments, laboratory data including USG - KUB, vital signs, physical examination, Enn vagai thervu, etc. were recorded in the CRF. The data collected in the CRF were analyzed statistically to evaluate the efficacy of Nanukkal parpam in Kalladaippu (Urolithiasis) patients.
H.Nalini Sofia
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World Health Organization (WHO) has highlighted the need to make sure quality control of Siddha formulations by using modern techniques and by using appropriate parameters and standards. Standardization of formulations and medicines are a major challenge. The safety, acceptability and efficacy of various drugs and formulations have to be documented before they can be promoted for human consumption. Nandukkal parpam is a herbo mineral siddha formulation prepared from Nandukkal a fossil stone crab is a marine product. It is one of the unique siddha medicine has not been dealt in any other AYUSH system especially prescribed for kidney diseases. The study focuses to determine the particle size of Nandukkal parpam in SEM Analysis and to detect the elemental compositions in EDAX Analysis. This study revealed that the minimum particle size of nandukkal parpam was 500 nm (nanometer) detected through SEM analysis which will increase the bio availability of the test substance. The elements present in nandukkal parpam are calcium, silicate, oxalate, aluminium, magnesium, potassium, chloride, and iron which may enhances the therapeutic efficacy of the drug.
H.Nalini Sofia
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Anti Microbial Screening of A Siddha Formulation Nandukkal Parpam
 
H.Nalini Sofia
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Nandukkal parpam is a siddha formulation indicated mainly for kidney diseases especially kidney stone. This drug was tested for anti microbial property against Proteus Vulgaris, E-cloi, Pseudomonas aeruginosa, Klebsiella pneumoniae and Staphylococcus aureus by Agar-disk diffusion method and the results obtained from the study showed that NKP has anti-microbial property against Proteus Vulgaris, E-cloi, Pseudomonas aeruginosa and the drug is not effective against Klebsiella pneumoniae and Staphylococcus aureus.
H.Nalini Sofia
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In India, 12% of the population is expected to have urinary stones, out of which 50% may end up with loss of kidneys or renal damage. Recurrent stone formation is a common problem with all types of stones and therefore an important part of the medical care of patients with stone disease. The researchers discovered that patients with stone formation had a 60% greater risk of developing Chronic Kidney Disease (CKD) and a 40% increased risk of developing end-stage renal disease (ESRD), the most severe form of CKD. Herbal medicines provide economical, effective, and time tested and considered safer than some of the modern synthetic drugs. Here we come across an astonishing therapy where the stones in the kidney are treated by Siddha herbal formulations. In the present study we have tried a combination of Keezhanelli chooranam, Silasatthu parpam and Nerunjil kudineer in the treatment of Kalladaippu showed best results. The main purpose is to focus the documentation of valuable Siddha formulations in treating kidney stones. 2 to 3 months of regular treatment with proper diet regimen has completely cured the disease (stone expelled/reduced stone size/ reduced the number of stones/avoidance of recurrence over a period of 12 months) when the stone size is 10mm.
H.Nalini Sofia
added 2 research items
The World Health Organization (WHO, 2002) emphasized development and utilization of herbal drugs and traditional medicines for the benefit of the world population in terms of cost effectiveness and low side effect. Plant medicines are in great demand both in the developed as well as developing countries for primary health care because of their wide range of biological and medicinal activities, higher safety margin and low cost. Many medicinal plants have been employed for centuries to treat urinary stones. The present review focus on the botanical information, Phytochemistry, Therapeutic uses, potential Pharmacological effect of some of the herbs, and Siddha formulations, being used in Siddha system of medicine for urolithiasis.
Objective: The present pilot study was designed to evaluate the effect of Nandukkal parpam (Calx of Fossil stone crab) a Traditional Siddha medicine in Kalladaippu (Urolithiasis) patients. Method: This study was conducted at the National Institute of Siddha, Tambaram, Chennai, India. The investigator recruited 10 patients with an inclusion and exclusion criteria. The patients were treated with 260 mg of Nandukkal parpam along with 50 ml Sirupeelai kudineer (freshly prepared decoction of the whole plant of Aerva lanata – Mountain Knot grass) twice a day for a period of 60 days. All the patients were taken laboratory investigations and Ultra Sono Gram (USG-KUB). Results: Normal sonographic study was observed in 6 patients and reduction in number of stones and stone size in 4 patients. There were no adverse events reported during the study and no recurrences during the follow up period of up to one year were reported. Conclusion: Results suggest that the trial drug Nandukkal parpam is effective and safe for the management of Kalladaippu (Urolithiasis) and in alleviating recurrences.
H.Nalini Sofia
added 2 research items
ABSTRACT Background: Kidney stone affect 10-12% of the population in industrialized countries. The average life time risk of stone formation has been reported in the range of 5-10%. Recurrent stone formation is a common part of the medical care of patients with stone diseases. The aetiology of this disorder is multi factorial and is strongly related to dietary lifestyle habits or practices. Increased rates of hypertension, diabetes and obesity which are linked to nephrolithiasis, also contribute to an increase in stone formation. Hence, this study was undertaken to find out the prevalence among kidney stone patients. Aim and objectives: To assess the prevalence of kidney stone among patients visiting in OPD-1, Dept.of Maruthuvam (Medicine), National Institute of Siddha and also to find out the risk factors influencing the development of kidney stones especially Family history, inadequate fluid intake, Stress, Over weight and Obesity, Dietary habits and lifestyle modifications, association with other diseases (diabetes, hypertension). Materials and methods: The study was conducted among 666 kalladaippu (kidney stone) patients. Details of factors influencing the formation of kidney stone were obtained using a pretested questionnaire. Results and conclusion: The study revealed a high prevalence of kidney stone is due to low fluid intake 72.07%(p=0.000), dehydration 67.56% (p=0.012) and dietary habits of mixed diet 91.59%(p=0.000),, high intake of coffee and tea 57.50%, sodium 64.26%, sugar 49.84%. Life style modifications of smoking 36.03%, alcohol consumption 41.59%, lack of physical activity 42.79%, obesity 54.80% also revealed a high prevalence of this disease. Key words: Kalladaippu, Kidney stone, risk factors, Siddha.
Nandukkal parpam is a herbo mineral siddha formulation extensively used in the treatment of Renal calculi. Physico chemical analysis of nandukkal parpam i.e. 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 was carried out in the present study. Qualitative analysis of the formulation showed the presence of elements of chlorides, phosphate, carbonate, silicate, iron and calcium. 19.87% of calcium content was found in the drug. No foreign matter was found out in this formulation.
H.Nalini Sofia
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This study consists of pre clinical and clinical evaluation of Nandukkal parpam. The pre clinical study included physico chemical analysis, Scanning electron microscope Analysis (SEM), Energy Dispersive X-Ray Analysis (EDAX), and Toxicity study of the test drug.Clinical study included pilot study and clinical trial as per GCP.