Role of Jaborandi in the treatment of Hypothyroidism: Pre and Post interventional trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Laboratory thyroid profile findings and Zulewskis clinical score will be reviewed at every 3 months of treatment for 6 months of study period
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Laboratory thyroid profile findings and Zulewskis clinical score will be reviewed at every 3 months of treatment for 6 months of study period
Time Frame: 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
Time Frame: Baseline, 3 months and 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Sophia Behera
National Institute of Homoeopathy