A Clinical Evaluation of Siddha Herbal Formulation Amalakathi Kirutham in the Treatment of Erigunmam (Acid Peptic Disease)

Abinaya Arulmalar, V (2022) A Clinical Evaluation of Siddha Herbal Formulation Amalakathi Kirutham in the Treatment of Erigunmam (Acid Peptic Disease). Masters thesis, National Institute of Siddha, Chennai.

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Abstract

The aim of the study is to evaluate the therapeutic efficacy of siddha herbal formulation Amalakathi kirutham in the treatment of Erigunmam. ❖ The protocol of the study has been approved by the Institutional Ethical Committee (IEC) of National Institute of Siddha. The date of IEC approval & IEC number is 21.12.2020; NIS/IEC/2020/D-1. The trial was registered in Clinical Trial Registry of India (CTRI Reg no: CTRI/2021/08/035861). ❖ The raw drugs were authenticated by Botanist. Medicinal Botany Department of NIS.(No: NISMB482021), and the study drug was prepared by the investigator in the Gunapadam lab, National Institute of Siddha, as per the standard operating procedure mentioned in the protocol. ❖ Biochemical analysis (Qualitative analysis) was done in the Biochemistry lab of NIS. Physico chemical analysis, Phytochemical analysis and heavy metal analysis were done at Noble research solutions, Perambur, Chennai. ❖ In this clinical study 67 patients were screened based on inclusion and exclusion criteria at the outpatient department of Maruthuvam, National Institute of Siddha. Out of 67 cases, 30 cases were recruited for the clinical study. ❖ Before commencement of the clinical trial, informed consent was obtained from all the patients. The patients were treated with Amalakathi kirutham within the duration of 48 days at the dosage of 4ml, twice a day before meal. ❖ The clinical assessment was done in the course of every visit of 7 days and the data were noteworthy in the Case Record Form. During the period of clinical trial there was no any adverse reaction recorded. ❖ The trial drug was play a vital role in the clinical trial, it neutralize the Pitham and Vaatham humors to all the patients. ❖ Blood parameters (CBC, LFT, RFT, Blood group and Lipid profile), were done before and after treatment. USG –Whole abdomen and Motion test was done only earlier to the treatment. ❖ Statistical Analysis was done after the completion of the treatment period for both before and after intervention. ❖ The statistically highly significant difference between before and after treatment with regard to the clinical symptoms were the subscale symptoms of GSRS were Reflux, Abdominal pain, Indigestion and Constipation, this is extremely significant (p<0.001**), Diarrhea symptom was less significant (p<0.0331) in the study. The laboratory investigations were Hemoglobin, Erythrocyte Sedimentation Rate, White Blood Cell Count, Basophil, High Density Lipoprotein, Low Density Lipoprotein, Serum Glutamate Oxalate Transaminase (p<0.000**) and The statistically significant difference between before and after treatment regarding the blood parameters were RBC-Red Blood Cell Count (p<0.002), P-Polymorphs (p<0.001), MMonocyte (p<0.12), E- Eosinophil (p<0.22), T.B- Total bilirubin (p<0.10), ALP- Alkaline phosphatase (p<0.016). ❖ According to Yugi Muni Vaithiya Chinthamani-800, The reduction of clinical features were burning or gnawing sensation after meals, bloating, abdominal flatulence, diarrhea, burping, sweating from hair follicles, twisting pain in intestine, Headache, Giddiness and Increased salivation showed the frequency table. ❖ According to Gastrointestinal Symptoms Rating Scoring scale (GSRS), the reduction of clinical symptoms were Abdominal pain, Heart burn, Acid reflux, Hunger pain, Nausea, Rumpling, Bloating, Burping, Passing gas / flatus, Diarrhea, Constipation, Loose stools, Hard stools, Urgency need to have a bowel movement, Sensation of not completely emptying the bowels. The statistical analysis was done and it showed the trial drug Amalakathi kirutham is more effective and significant in Erigunmam (Acid Peptic Disease) patients.

Item Type: Thesis (Masters)
Additional Information: Reg.No.321911201
Uncontrolled Keywords: Clinical Evaluation, Siddha Herbal Formulation, Amalakathi Kirutham, Treatment, Erigunmam, Acid Peptic Disease.
Subjects: AYUSH > Maruthuvam
Depositing User: Subramani R
Date Deposited: 01 May 2023 06:39
Last Modified: 14 Feb 2024 01:47
URI: http://repository-tnmgrmu.ac.in/id/eprint/21139

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