Evaluation of Clinical Efficacy of Urai Mathirai as Immuno Modulator

AIM AND OBJECTIVES: The primary and secondary objectives of the study are as follows: 1. To pharmacognostically identify the selected individual plant Chukku (Zingiber officinale), Athimathuram (Glycyrrhiza glabra), Akkarakaram (Anacyclus pyrethrum), Vasambu (Acorus calamus), Jathikkai (Myristica fragrans), Kadukkai (Terminalia chebula), Masikkai (Quercus infectoria), Poondu (Allium sativum), Perunkayam (Ferulla asafoetida), Thippili (Piper logum) for authentication. 2. To develop the Urai Mathirai (Siddha formulation) from the above herbs. 3. To investigate the phytochemical potential of individual plant crude powders and Urai Mathirai (Siddha formulation) by Chemical tests, HPTLC. 4. Evaluation of formulation by standard parameters as per AYUSH guidelines. 5. To develop and analyze tablet by Pre - formulation and Post - compression studies. 6. To analyze the Urai Mathirai (Siddha formulation) for In - Vitro studies like Anti-Oxidant, Anti- Inflammatory, and Anti- Microbial activities. 7. To assess the safety of the Urai Mathirai (Siddha formulation) according to OECD guidelines by animal models. 8. To evaluate the Urai Mathirai (Siddha formulation) for In - Vivo studies like Anti- Inflammatory, Immuno modulatory and Analgesic activities. 9. To evaluate the clinical efficacy of the trial drug in controlling repeated Respiratory infections with an active control in parallel to evaluate its efficacy and increasing the time gap between episodes. 10. To bring down evidence and scientific support for the Urai Mathirai - a traditional Siddha formulation. SUMMARY: The question of efficacy of Urai Mathirai as Immunomodulator and its usage to children was tested with a Null hypothesis that Urai Mathirai is not beneficial as an Immunomodulator. To test this Urai Mathirai was prepared meticulously as per Hospital pharmacopeia of Indian medicine. However, the Bullet shaped rubbing pills were replaced with 50mg tablets as per specific SOP. The tablet matched with the standards prescribed by PLIM and also other parameters for tablets. While preparing all the drugs were authenticated. Pharmacognosy, Physico chemical and phytochemical testing was done as per guidelines. The results revealed the purity of the drug as it is free from heavy metals, Aflatoxins, and Microbial load. In vitro studies for Antioxidant, Anti-Inflammatory and Immunomodulatory effects proved the basic claim of the drug and anti-microbial activity proved the efficacy of drug against certain bacteria. In vivo Safety and Pharmacological studies revealed Nontoxic nature and effectiveness of drug. Anti-inflammatory analgesic and Immunomodulator activity of the drug reassured its traditional claim. Clinical trial carried out helped in proving the efficacy of Urai Mathirai on par with the official siddha formulation Thaleesathi chooranam in controlling repeated respiratory infections. The outcome measures clearly assured the efficacy of Urai Mathirai and proved that Urai Mathirai decreases the disease burden. Four main variables tested helps in proving the claim of the drug’s use in Mantham, Kanam and Loss of appetite. CONCLUSION: Its concluded that preclinical and clinical studies carried over prove that Urai Mathirai possess immuno modulator activity evinced through in vivo Immunomodulatory studies and also by reduction in repeated respiratory infections and disease burden reduction in Clinical trials

MANAGEMENT OF NON COMMUNICABLE DISEASES BY SIDDHA SYSTEM

Background: Siddha System is a Philosophy based Medicine that deals with Holistic approach to health. Basically it’s a way of life that emphasizes Positive health. The essential life style for healthy living has been formulated in Siddha system of Medicine, according to the Geographical and Seasonal variations. As per Siddha concept, there is vitiation of three humours namely Vatham, Pittham and Kapham because of food habits and actions. This Paper addresses the problem of Non Communicable Diseases in this decade and discuss about its prevention by means of health measures in Siddha System. The measures for the Management of NCDs includes Regular Physical activity, Balanced diet and liquor, Regular sleep, Stress-free life, Pursuance of hygienic measures described in Siddha Literatures, Cessation of habits like Smoking and Alcohol consumption and then acclimatization of body to climatic variation. Aim & Objective: The rationale of this paper is to highlight the extent of the problem and threats posed by the life style modification in current scenario, and finally address the way of intervention by means of Siddha Principles. Conclusion: As the current scenario of life-style results in multiple complications like Physical and Metabolic derangement of the body, the follow up of rules and regulations (Daily and Seasonal regimen) mentioned in Siddha System is the proper way for the prevention and Management of NCDs

A REVIEW ON SCOPES, METHODS AND RATIONALE OF INTEGRATIVE APPROACH IN SIDDHA MEDICINE WITH BIOMEDICINE

In India, according to WHO 2018 statistics, there were 63% of death occurred due to Non-communicable diseases (NCDs), in which Cardiovascular diseases were leading cause of death 27%, followed by Cancer 9%, Chronic respiratory disease 11%, Diabetes 3% and other NCDs 13%. This indicates that NCDs needs to become a priority in controlling and preventing. Therefore, the only effective intervention may be at controlling and preventing NCDs disease is Integrative Medicine. Integrative Medicine is a medical practice synthesizing Traditional medicine and Biomedicine preventive measures and treatment interventions. Autonomy of patients may end in no benefit out of their ignorance to select between the treatment options available in a country like India where Seven Recognized medical systems are available as a platter. Siddha system of medicine is one of the traditional medicines of India, practiced in the southern part of the country. This study aims at providing Health care system under one roof, in order to save public money, time and health as an existing model as co-location in Tamil Nadu. This can be achieved through assessing feasible areas of integration in the Siddha system of medicine with biomedicine. So the study deals with the utilization of Siddha system of medicine, scientific validation of Siddha medicines, Siddha medicine research undertaken by biomedical practitioners and some government policies supporting mainstreaming of Siddha

ANALOGIZING OF METABOLIC SYNDROME IN SIDDHA SYSTEM OF MEDICINE-A LITERATURE REVIEW

Background: In worldwide, 20-25% of the population have the Metabolic Syndrome (MetS). The highest prevalence rate reported in South Asia of MetS in the Punjabi community in India by Adult Treatment Panel III criteria. The metabolic syndrome (MetS) is a major and escalating public-health and clinical challenge worldwide in the wake of rapid urbanization, surplus energy intake, increasing obesity, and sedentary life habits. Nowadays, the use of Complementary and Alternative Medicine (CAM) is increasing rapidly due to the inadequate solution for the newly developed health issues. Method: In this study, the International Diabetic Federation (IDF) criteria were used as a standard tool for comparison. A total of 9 sources (4 Siddha classical textbooks, e-data such as pub-med, Google scholar, AYUSH research portal, NAMSTP) were searched to identify the appropriate analog for MetS. Results: 13 Terms related to MetS were identified from the 4 Siddha classical literature, whereas the e-data did not provide any term related to MetS. In those 13 terms, 3 terms which were closely relevant to MetS signs and symptoms were Aiya Migu Kunam, Paci Aiya Noi, and Megam. As a final point, this paper identified the Siddha analog for MetS as Aiyamigukunam. Conclusion: This paper ended up with analog to MetS as Aiyamigukunam and made a comparison with the standard IDF criteria for MetS

Antiviral activity of ethanolic extract of Nilavembu Kudineer against dengue and chikungunya virus through in vitro evaluation

Abstract Background Currently, no vaccines or modern drugs are available for dengue and chikungunya and only symptomatic relief is provided to the patients. Siddha medicine, a traditional form of indigenous medical system uses specific polyherbal formulations for the treatment of such infections with considerable success. One such polyherbal formulation for the treatment of chikungunya and dengue is Nilavembu kudineer (NVK). The mechanistic details of this drug as an antiviral for chikungunya virus (CHIKV) and dengue virus (DENV) is poorly understood. Objectives The current study was undertaken to study the efficacy of NVK as an antiviral formulation against CHIKV and DENV. Materials and methods Cytotoxicity assays (MTT) were performed to determine the role of NVK as an antiviral during chikungunya and dengue infections in the following conditions-i). post infection, ii). during active infections and iii) protective, not allowing virus infection. Results It was observed that NVK provides protection against CHIKV and DENV-2 during active infection as well can help to prevent virus infection in the cells and it mainly depends on the cellular availability of drugs for maximum protection against both the infections. Conclusion Our study establishes that extraction protocols are important to ensure maximum efficacy of NVK along with the time of addition of the drug during CHIKV and DENV infections in the cells. This study provides insights to the possible mode of action of NVK in in vitro condition during CHIKV and DENV infection

Monograph on quality standards of Viscum angulatum B. Heyne ex DC.

The genus Viscum (Viscaceae) comprise of several species of hemi-parasitic plants with medicinal properties. Commonly known as mistletoes, these plants grow on other trees with the partial parasitic association. Viscum angulatum B.Heyne ex DC. is one such less explored leafless mistletoe of Asian countries with medicinal claims. In Ayurveda (Bandaka) and Siddha (Pulluri/Pulluruvi), many botanicals from mistletoe families have been attributed with medicinal properties. The objective of the current study is to develop a monograph on quality standards of V. angulatum occurring in high altitude hills of Western Ghats. Aerial parts of V. angulatum were collected and authenticated and preserved in FAA for microscopic studies and some quantity of the plant material was shade-dried and coarsely powdered. Successive extracts were subjected to chromatography and isolation - characterization of the major compounds. Leaf-less quadrangular stem was found to be a diagnostic macroscopic feature of this species. The preliminary phytochemical investigation of extracts showed presence of alkaloids, carbohydrates, coumarins, flavonoids, phytosterols, triterpenoids, saponins and tannins. HPTLC fingerprint of n-hexane and ethyl acetate extracts has been obtained for identification of extracts. The ethyl acetate extract yielded 10-hydroxyoleoside dimethyl ester which can be used as a marker compound for routine quality check of V. angulatum growing on Mussaenda hirsutissima. The set of data obtained in the present investigation can serve as a standard for the identification as well as further studies. These results on standards of this plant are the first report so far

Monograph on quality standards of Viscum angulatum B. Heyne ex DC.

320-332The genus Viscum (Viscaceae) comprise of several species of hemi-parasitic plants with medicinal properties. Commonly known as mistletoes, these plants grow on other trees with the partial parasitic association. Viscum angulatum B.Heyne ex DC. is one such less explored leafless mistletoe of Asian countries with medicinal claims. In Ayurveda (Bandaka) and Siddha (Pulluri/Pulluruvi), many botanicals from mistletoe families have been attributed with medicinal properties. The objective of the current study is to develop a monograph on quality standards of V. angulatum occurring in high altitude hills of Western Ghats. Aerial parts of V. angulatum were collected and authenticated and preserved in FAA for microscopic studies and some quantity of the plant material was shade-dried and coarsely powdered. Successive extracts were subjected to chromatography and isolation - characterization of the major compounds. Leaf-less quadrangular stem was found to be a diagnostic macroscopic feature of this species. The preliminary phytochemical investigation of extracts showed presence of alkaloids, carbohydrates, coumarins, flavonoids, phytosterols, triterpenoids, saponins and tannins. HPTLC fingerprint of n-hexane and ethyl acetate extracts has been obtained for identification of extracts. The ethyl acetate extract yielded 10-hydroxyoleoside dimethyl ester which can be used as a marker compound for routine quality check of V. angulatum growing on Mussaenda hirsutissima. The set of data obtained in the present investigation can serve as a standard for the identification as well as further studies. These results on standards of this plant are the first report so far

Traditional methods of purification (detoxification process) for Schedule E poisonous drugs

Medicinal plants have different types of active phytochemicals, which are still in use, either in their crude form or after proper processing. Though most of the plant drugs are safe, few are poisonous and may cause immediate toxic effect or cumulative toxic effect for human health. There are 25 poisonous or toxic plants in Siddha texts listed in the Schedule E of Drugs and Cosmetics Act 1940. The concept of Suthimuraigal in Siddha not only covers the process of purification and detoxification of physical and chemical impurities but also minimizes the side effects and improves the potency/therapeutic efficacy of the purified drugs. The aim of this review is to perceive the importance of the Schedule E drugs through their immense uses to treat diseases and to flourish the knowledge of purification processes to detoxify the poisonous elements, thus enhancing and utilizing them in curing challenging diseases. The distinct purification methods mentioned in Ayurvedic journals have also been reviewed for possible information. Methods of Suthi are variable and some of the important Siddha Suthimuraigal are reviewed in this paper. The traditional methods of purification may combat the toxic effects like ulceration, swelling, giddiness, skin rashes, pruritis also, thus enhancing the efficacy of the drugs in healing various ailments. Since these poisonous plants have very high potential to treat diseases, the chemical changes which transpired during the Suthi are to be revealed in further studies such as quantitative and qualitative analysis after their purification before they are applied in medicines

Traditional methods of purification (detoxification process) for Schedule E poisonous drugs

740-748Medicinal plants have different types of active phytochemicals, which are still in use, either in their crude form or after proper processing. Though most of the plant drugs are safe, few are poisonous and may cause immediate toxic effect or cumulative toxic effect for human health. There are 25 poisonous or toxic plants in Siddha texts listed in the Schedule E of Drugs and Cosmetics Act 1940. The concept of Suthimuraigal in Siddha not only covers the process of purification and detoxification of physical and chemical impurities but also minimizes the side effects and improves the potency/therapeutic efficacy of the purified drugs. The aim of this review is to perceive the importance of the Schedule E drugs through their immense uses to treat diseases and to flourish the knowledge of purification processes to detoxify the poisonous elements, thus enhancing and utilizing them in curing challenging diseases. The distinct purification methods mentioned in Ayurvedic journals have also been reviewed for possible information. Methods of Suthi are variable and some of the important Siddha Suthimuraigal are reviewed in this paper. The traditional methods of purification may combat the toxic effects like ulceration, swelling, giddiness, skin rashes, pruritis also, thus enhancing the efficacy of the drugs in healing various ailments. Since these poisonous plants have very high potential to treat diseases, the chemical changes which transpired during the Suthi are to be revealed in further studies such as quantitative and qualitative analysis after their purification before they are applied in medicines

Management of Rheumatoid Arthritis in Siddha System of Medicine - A Case report

A case of Uthiravathasronitham (Rheumatoid arthritis) had been treated with a classical Siddha preparation Rasa chenduram (100mg) along with Thirikadugu choornam (1 gm) for 3 weeks and with Pinda thailam as an external application. The patient condition has been assessed by a validated simplified disease activity measurement tool for Rheumatoid arthritis by Disease activity score (DAS) with 28 joints and formula using Erythrocyte sedimentation rate (ESR) as recommended by EULAR (European League against rheumatism) criteria. The functional status of the patient was evaluated by administering the Health assessment questionnaire disability index (HAQ-DI) and Visual analog scale (VAS) score before and after treatment. The treatment yielded moderate improvement in the patient’s health condition