跳至主要内容
临床试验/CTRI/2024/04/066453
CTRI/2024/04/066453尚未招募2 期

Role of Jaborandi in the treatment of Hypothyroidism: Pre and Post interventional trial

National Institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
34
试验地点
1
主要终点
Laboratory thyroid profile findings and Zulewskis clinical score will be reviewed at every 3 months of treatment for 6 months of study period

研究概览

简要总结

Following preliminary screening for hypothyroidism symptoms and detailed screening using specified selection criteria, eligible patients will be recruited in the trial

Following that, outcome data will be obtained

A detailed and thorough case taking of each and every eligible patient will be done according to the format prevalent in National Institute of Homoeopathy, 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 symptoms will be matched against the symptoms of Jaborandi and if at least 50 percent symptoms which has given below,  would be present then it will be included in the study

SYMPTOMS OF JABORANDI

1 Mentally dullness

2 Headache from using eyes

3 Everything at a distant appear hazy

4 Hair loss

5 Dryness of skin

6 Flushing of face

7 Profuse salivation

8 Profuse perspiration

9 Deafness

10 Intense thirst

11 Profound sleep

12 Constipation

13 Worse from cold

Every patient will be assessed periodically to follow up the reaction of the remedy through Serum Thyroid profile test and Zulewskis clinical score every 3 monthly

The usual follow up will be done at an interval of 4 weeks and will be recorded in follow-up sheets

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
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of both sexes Aged 20-70 years Patient of all socio-economic classes Patient with Serum TSH level ≥6 mIU/L Patients having at least 50% symptoms of Jaborandi as given in Appendix 8 Patients agree to undergo some investigation, if required Patients willing to give written consent to participate in the study.

排除标准

  • TSH level less than 6 mIU/L Pregnant or lactating women Patient taking any other treatment for Hypothyroidism from other system of medicine Patient has habit of substance abuse and/or dependence Patient having any Psychiatric or life-threatening illness or Immuno-compromised state Patients not willing to undergo any investigation, if so advised.

结局指标

主要结局

Laboratory thyroid profile findings and Zulewskis clinical score will be reviewed at every 3 months of treatment for 6 months of study period

时间窗: Baseline, 3 months and 6 months

Zulewskis Clinical Score (ZCS) for hypothyroidism This simple scoring system is based on 7 subjective symptoms and 5 physical signs of hypothyroidism Each symptom or sign if present gets 1 point and if absent gets 0 point It’s a 0 to 12 scoring scale, if total scoring more than 5 it defines hypothyroidism and if scores in between 0 and 2, it defines euthyroid status This scale was originally written in English

时间窗: Baseline, 3 months and 6 months

次要结局

未报告次要终点

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sophia Behera

National Institute of Homoeopathy

研究点 (1)

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