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临床试验/CTRI/2024/02/062939
CTRI/2024/02/062939尚未招募4 期

A COMPARATIVE CLINICAL ANALYSIS OF THE EFFECTIVENESS OF THYROIDINUM 3X AS AN INTERVENTIONAL TREATMENT FOR PAEDIATRIC HYPOTHYROIDISM

Apparna Ilankumaran1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月2日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Paediatric Hypothyroidism is one of the areas of increasing concern in the present-day

研究概览

简要总结

Paediatric Hypothyroidism is a significant endocrine disorder characterized by an insufficient production of thyroid hormones in children. This condition is of paramount concern due to the crucial role thyroid hormones play in growth, development, and overall metabolic regulation during childhood. The prevalence of Paediatric Hypothyroidism varies globally, with congenital forms being particularly common. The aetiology can range from genetic factors to iodine deficiency, autoimmune disorders, and medication-induced hypothyroidism. Early diagnosis and intervention are crucial to mitigate these potential long-term consequences, while untreated or inadequately managed hypothyroidism can lead to a range of detrimental effects, including stunted physical growth, cognitive impairment, and delayed puberty. With advances in medical diagnostics and treatment modalities, timely identification and management of Paediatric Hypothyroidism have become more feasible, significantly improving the prognosis and quality of life for affected children. However, there remains a need for continued research to refine diagnostic approaches, treatment strategies, and long-term outcomes, ensuring that every child with hypothyroidism receives the best possible care. Exploring Homoeopathic treatment for Paediatric Hypothyroidism is warranted for several compelling reasons. While conventional medical approaches, such as levothyroxine supplementation, have demonstrated effectiveness, there is growing interest in complementary and alternative therapies. Homeopathy, a system of medicine based on individualized treatment with highly diluted substances, offers a holistic approach that may be particularly relevant in paediatric cases. This study aims to identify and explore the inclusion of Thyroidinum 3X in the therapeutic spectrum and assess its effectiveness in managing Paediatric Hypothyroidism

AIM:

To evaluate the efficacy of Homeopathic medicine Thyroidinum 3X as an interventional approach in comparison to Predetermined Homoeopathic medicines for Paediatric hypothyroidism.

OBJECTIVES:

To evaluate the action of Thyroidinum 3X in Paediatric Hypothyroidism.

To assess which predetermined Homoeopathic medicine has more effectiveness when

administered along with Thyroidinum 3X for Paediatric Hypothyroidism

To understand the cause of Paediatric Hypothyroidism.

SCREENING:

Cases diagnosed with Paediatric hypothyroidism from  the OPD’s, IPD’s and Rural health centres of SKHMC will be considered for the study, based on the satisfaction of inclusion criteria.

MATERIALS:

Standardized case record format of SKHMC and TFT reports.

SAMPLE SIZE:

The 30 cases satisfying the inclusion criteria will considered for the study and then will be randomly categorized into 2 groups, with 15 each. Patients in group 1 will be administered with Constitutional medicine will the patients in group 2 will be administered with constitutional medicine along an interventional medicine Thyroidinum 3X,  for a required duration. The TFT reports will be analysed every 3 months with a regular follow up for every month.

ENROLLMENT:

Patients within the Paediatric age group 1-18 years of age.

Patients of both sexes.

Patients diagnosed with Clinical and Subclinical Hypothyroidism

Patients with a TSH level below 20mUI/ml.

STUDY PERIOD: 1 year

FOLLOW UP: Regular follow up every month, TFT every 3months

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Patients within the Paediatric age group 1-18 years of age.
  • Patients of both sexes.
  • Patients diagnosed with Clinical and Subclinical Hypothyroidism Patients with a TSH level below 20mUI/ml.

排除标准

  • Patients with congenital and autoimmune thyroid disorders Patients with other systemic diseases.

结局指标

主要结局

Paediatric Hypothyroidism is one of the areas of increasing concern in the present-day

时间窗: General follow up every month, with TDT review every 3 months

generation. With various other research being conducted in the area of hypothyroidism, the

时间窗: General follow up every month, with TDT review every 3 months

Homoeopathic method of treatment serves to be one of the safer and gentler methods for the

时间窗: General follow up every month, with TDT review every 3 months

restoration of health. The outcomes of this study pave way for the further research to be done

时间窗: General follow up every month, with TDT review every 3 months

and also help us to identify the validity of the use of Thyroidinum 3 X in such cases.

时间窗: General follow up every month, with TDT review every 3 months

次要结局

未报告次要终点

研究者

发起方
Apparna Ilankumaran
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Apparna Ilankumaran

Sarada Krishna Homoeopathic Medical college

研究点 (1)

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