ROLE OF INDIVIDUALISED HOMOEOPATHIC MEDICINE IN THE MANAGEMENT OF PRIMARY AQUIRED HYPOTHYROIDISM IN PAEDIATRIC AGE GROUP: A SINGLE ARM PRE-POST INTERVENTIONAL STUDY
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Serum TSH Values
研究概览
简要总结
Acquired hypothyroidism, also known as juvenile hypothyroidism, results from insufficient thyroid hormone production, leading to metabolic and neurological effects at the cellular level. It can manifest as overt hypothyroidism, where thyroid hormone levels (T4 and T3) decrease, and thyroid-stimulating hormone (TSH) levels increase.
· Following preliminary screening for hypothyroidism and detailed screening using specified selection criteria, eligible patients will be recruited in the trial. Following that, outcome data will be obtained.
· Specific laboratory investigations which help for the diagnosis and classification of the hypothyroidism will be advised accordingly (Serum Anti-thyroid peroxidase antibody (anti- TPO), anti-thyroglobulin antibodies (TgAb), USG Thyroid).
· A detailed and thorough case taking of each and every eligible patient will be done according to the format prevalent in N.I.H, Kolkata, as per strict homoeopathic principles.
· Clinical examination or relevant investigations will be done as per need.
· Inclusion and exclusion criteria, as mentioned above, will be followed
· Each case will be studied properly through analysis and evaluation of symptoms and the individualized homoeopathic medicine is selected according to the totality of symptoms.
· Every patient will be assessed periodically to follow-up the reaction of the remedy through Serum TSH, Zulewski’s clinical score at baseline and after 6 months of treatment. MONARCH will be calculated after the study. The usual follow up will be done at an interval of 4 weeks and will be recorded in follow-up sheets.
· Outcome of the treatment will be assessed by considering the symptomatic improvement of the patients and on the changes in TSH level.
· Final evaluation of the data will be done by means of appropriate statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with serum thyroid stimulating hormone (TSH) value more than 5.5 mlU/L to 100 mlU/L.
- •Patients with onset of symptoms mentioned in the Zulewski clinical score exceeding 3 months.
- •Patient with age group of 4-17 years.
- •Patients of all sexes, religions and socio-economic conditions.
- •Patients who have not taken any treatment in the last 4 weeks for hypothyroidism.
- •Patients or parents/guardians of patients who can read/ write/understand either English, Hindi or Bengali languages
- •Patient parents who are willing to give written informed consent and to participate in the study and give verbal (children aged between 7-12 years) or written assent (children aged between 12-17 years).
排除标准
- •Patients with congenital hypothyroidism, thyroid dysgenesis (aplasia, hypoplasia, ectopic gland).
- •Patients with central hypothyroidism.
- •Patients with thyroid malignancies.
- •Post ablative hypothyroidism
- •Cases with substance abuse or any psychiatric illness.
- •Congenital anomaly, critically ill and immune-compromised patients.
- •Children suffering from uncontrolled systemic diseases.
结局指标
主要结局
Serum TSH Values
时间窗: Measured at baseline and after 6 months of treatment
次要结局
- Zulewski’s Clinical Score (ZCS) for hypothyroidism more than 5(Measured at baseline and after 6 months of treatment)
- Modified Naranjo criteria for homoeopathy(Measured at the end of 6 months)
研究者
DR AKSHAYA THANKACHAN
NATIONAL INSTITUTE OF HOMOEOPATHY ,KOLKATA