Arul Mozhi, P (2016) Safety and Efficacy of Siddha Medicines and Methodologies for the Management of Special Children. Doctoral thesis, The Tamilnadu Dr. M.G.R. Medical University, Chennai.
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Abstract
INTRODUCTION: “Special children” is common term describe to categorize conditions such as childhood developmental disability caused by neuronal damage. Health and lifestyle early in life have profound impact on health and quality of life in later years. The proportion of disabled children in developing countries is generally higher than in developed countries, it is estimated that 6 to 10% of children in India are born disabled. Developmental disabilities are some of the most upsetting for a family to deal. Diagnoses like cerebral palsy, Autism, Down syndrome, ADHD and intellectual disabilities often cause children to be removed from the mainstream, and parents must be brutal advocates to make sure their children receive the services, therapy, and inclusion they need and deserve. At present, no health care profession has convincingly assumed the responsibility of the health for special children. Although drug therapy may not completely correct complications associated with childhood disability, evidence does show that it helps manage problems. Various factors influence the choice of a treatment modality, i.e children’s age, physical body, future risk of musculoskeletal deformities, developmental potential, and neurological progression impact this decision making process. There are many physical disabilities that can affect children. But cerebral palsy (CP) is the most common physical disability in childhood. AIM OF THE STUDY: To evaluate the safety and efficacy of Siddha methodologies and medicines for the management of Special children (Cerebral Palsy). OBJECTIVES: 1. To evaluate the physicochemical standardization and HPTLC of Brahmi Nei. 2. To study the pre clinical and clinical safety of the experimental formulation. 3. To evaluate the clinical therapeutic efficacy of experimental formulation, Thokkanam (Massage) and Varmam in cerebral palsy children under the following parameters: (a) Spasticity in upper and lower limb muscles, GMFCS, muscle tone, dynamic gait index and selective control assessment of joints, fine motor functions of the upper limb. (b) Assessments of language and vocabulary, social and emotional skills, cognitive skills, functional and adaptive behavior skills. 4. To evaluate Siddha philosophies for the management of cerebral palsy. MATERIALS/PATIENTS AND METHODS: Raw drugs to prepare the experimental formulation were purchased from the market and fresh plants were collected from wild sources. Care was taken to select healthy plants for normal organs. The specimens would be authenticated with the standard specimens kept in the Department of pharmacology and medicinal botany in the National institute of Siddha. Authenticated raw drugs were preserved for sample used to prepare Experimental formulations. Birahmi Nei was prepared as described as in the sasthric Siddha literature. Briefly, it was prepared by adding paste of Zingifer officinale Linn., Piper longum Linn., Alpenia officinarum Linn., Feronia elephantum Linn., Induppu, Caryyota urens Linn., Gurkuma aromatic Linn., in freshly prepared Bacopa monniera Linn., Acorus calamus Linn., Alpenia galanga Linn., and in vessel having Cow‟s milk, Cow‟s Ghee,. Above mixture was heated and filtered after acquiring completion test. In this way, Birami Nei was prepared. RESULTS: Brahmi Nei was analyzed to obtain parameters, such as, Description – Colour, Odour, Weight/ml, Refractive index at 25 ºC, Iodine value, Saponification value, Acid value, Test for heavy metals – Lead, Cadmium, Mercury, Arsenic, Microbial contamination - Total bacterial count, Total fungal count, Test for specific Pathogen - E. coli, Salmonella spp., S.aureus, Pseudomonas aeruginosa, Pesticide residue - Organochlorine pesticides, Organophosphorus pesticides, Pyrethroids, according to the Quality Control Manual of Ayurveda, Siddha, and Unani Medicine (the standard protocol mentioned in books). The results showed (Table 6.1-6.4) Brahmi Nei was yellowish green in colour and characteristic ghee smell and aromatic odder of Brahmi. Refractive index was 1.4552 – 1.4582. Brahmi Nei had Acid value, Iodine value Saponification value respectively 5.21 to 10.91, 32.35 – 34.75, 159.02 - 227.2. It has shown that all the levels of Lead, Cadmium, Mercury, Arsenic toxic heavy metals analyzed were not detectable. For the evaluation of microbial contamination, total bacterial and fungal content were less than 10 cfu/ml. In specific pathogen analysis E. coli, Salmonella spp., S.aureus Pseudomonas aeruginosa were totally absent. All the pesticide residue and aflatoxins showed absent (Table -6.3). HPTLC study was done to obtain the fingerprints of the Brahmi Nei and it was also done to get standard markers. In the present study, HPTLC densitometric scan (Plate 6.1) of petroleum ether extract of unsaponifiable matter of Brahmi Nei at 366 nm showed 6 peaks which covered the area of corresponding Rf values. Maximum spots were observed in our sample which indicates more active constituents in it. These are the standard markers of the components which can be used as referral standards. CONCLUSION: Brahmi Nei has proven its ability in sensory functions connecting parameters such as visual, hearing and vocal in GMFCS, language, cognitive, socio-emotional and behavior skills. Children who received Brahmi Nei alone showed prognosis in above said parameters. Children who received massage showed improvement in motor parameter such as spasticity, muscle tone, GMFCS, gait, stiffness in the joints and fine motor functions of the upper limb. Children who received Brahmi Nei, Thokkanam and Varmam showed significant improvement in all sensory and motor parameters. Hence, it can be concluded that combined therapy has a definitive action as well as therapeutic efficacy on spastic type of cerebral palsy in children in contrast to single therapy. The effects of internal and external therapies may be due individual drugs‟ multipronged action. Further study is required for scientific validation to prove its clinical efficacy in multicentre clinical study.
| Item Type: | Thesis (Doctoral) |
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| Uncontrolled Keywords: | Safety, Efficacy, Siddha Medicines, Methodologies, Management, Special Children. |
| Subjects: | AYUSH > Kuzhanthai Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 24 Sep 2019 01:33 |
| Last Modified: | 24 Oct 2022 16:55 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/11560 |
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