Safety and Clinical evaluation of siddha drug Poonaikali Vithai Chooranam in the treatment of Aan Maladu (Male Infertility)

Rajendran, K (2017) Safety and Clinical evaluation of siddha drug Poonaikali Vithai Chooranam in the treatment of Aan Maladu (Male Infertility). Masters thesis, National Institute of Siddha, Chennai.


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In developing country like India, one in every four couples found to be affected by infertility. In 2010 almost 50 million couples world wide unable to have a child after five years of marriage. Infertility rate has hardly changed over the past 20 years. The global health community has made great success in improving the infertility care in the past decade. Infertility can lead to distress and depression as well as discrimination and ostracism. infertility can be caused by poor sexual life style habits that are easily remedied. Heavy usage of alcohol, tobacco drugs, tight underwares or pants which raise the scrotal temperature and reduce the sperm count. Infections play an vital role in male infertility that block the ducts through which the sperm travels. Exposure to metals such as lead, chemical and pesticide plays a major role in male infertility.Auto immunity in which antibodies or cells of the human immune system attack sperm cells mistaking them as toxic invaders. Now a days male infertility treatment is a challenging task. In recent years siddha system of medicine have bloomed up in treating male infertility with high success rate. The main aim of this study is to document the effectiveness of siddha medicine poonaikali vithai choornam (Internal medicine) in the management of AANMALADU (Male infertility). The objective of this study is the Preclinical and Clinical Studies. Preclinical studies consist standardisation and safety of the study of drug.Clinical studies conducted in 40 cases. The raw drug were purchased from reputed country medical shop in Chennai and drug authentication by Botanical of NIS. The drug was prepared as per standard operating procedure mentioned in the siddha literature in Gunapadam laboratory of National Institute of Siddha. The standardization of study drug was carried out in the Biochemistry lab of NIS. It revealed the presence of chloride, fluoride, carbonate with the study drug. The preclinical toxicity studies (Acute and repeated oral 28 days toxicity) for the above said study drug was conducted at Pharmacology laboratory, C.L.Baid Metha college (IAEC NO: IAEC/XLIX/13/CLBMCP/2016). The study drug was found to the usage as per the data generated from the studies. The histopathological studies did not reveal any abnormalities in the animals in both control and test group revealed that the drug was non-toxic. The clinical study was conducted with a well defined protocol and a proper proforma after getting the approval of the Institutional Ethical Committee. (IEC NO:NIS/IEC/9/2014-15/7-26.08.2015. The study data were registered in CTRI ( Clinical Triall Registry of India) with ID NO: CTRI/2016/07/011882. After screening 60 cases study based on the inclusion criteria and exclusion criteria reporting at the OPD of Maruthuvam, 40 cases were selected for induction to the study. Before enrolment into the trial the informed consent was obtained from the patients. The aim of the study is to increase the sperm count and sperm motility in male infertility patients. The duration of administration of study drug 48 days. The study drug dose was 6grams twice a daily with cow ghee. Before Starting the treatment semen analysis, routine blood and urine examination were taken in all 40 patients. Siddha methods like three Humor, Thegi, Kosangal, udal thathukkal, Envagai thervu, neeikuri, nerkuri and buoyancy of Semen on water were analysed in all 40 Cases.Out of 40 Patients 30 Patients Presence with following Symptoms Premature ejaculation, Erectile dysfunction, Painful micturition, Nocturnal emission.The remaining 10 Patients were symptoms free but their clinical lab semen analysis report showed low sperm count and motility problem with The entire details were noted in the selection proforma. Patients were instructed to come for clinical once in 12 days. They were also instructed to bring back the unconsumed drug during the next visit and return the same.In every visit the clinical assessment was made. At the end of the treatment reduction of clinical symptoms and improvement in clinical lab para meters (Sperm count and motility)in all the 40 patients. Improvement in the Sperm count with in 5 million and more than 5 to 10 million were report in cases each 5%. More than 11 to 20 million was found in cases 10%. More than 21 to 30 million was found in 20% of cases. More than 30 million was reported in 60% of cases. Improvement in the active motility with the range of 50%-70% in 24% of cases. 50%-60% in 41% of cases. 50% in 10% of cases. Less than 50% in 25% of cases were observed. 30patients complaining regarding secondary sexual characters showed improvement. 18 patients attained the stage of fertilization. After the treatment no side effects were noted. The cost of medicine is comparatively low. The ingredients were easily available and the rural people will be benefited more. I have concluded the siddha medicine Poonaikali vithai choornam was effective in treatment of ―Aan maladu‖ (Male infertility especially oligospermia and asthenozoospermia).

Item Type: Thesis (Masters)
Additional Information: (Reg. No: 32141107)
Uncontrolled Keywords: Siddha drug ; Poonaikali Vithai Chooranam ; Aan Maladu ; Male Infertility ; Clinical study.
Subjects: AYUSH > Maruthuvam
Depositing User: Kambaraman B
Date Deposited: 23 Sep 2018 08:18
Last Modified: 23 Sep 2018 11:01

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