A Clinical pilot study to evaluate effect of Nano Kanchanara Twak extract Capsule (Ayurvedic Medicine) in Hypothyroidism patients
Phase 2
- Conditions
- Health Condition 1: E039- Hypothyroidism, unspecified
- Registration Number
- CTRI/2022/05/042402
- Lead Sponsor
- Dean Faculty Of Ayurved
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Patients of either gender with age group 20-60 Years (both years inclusive)
2) Elevated level of serum TSH more than normal range (i.e. 0.4 -5.0 μIU/ml)
3) Patients having clinical features of hypothyroidism-
a. Puffiness of face and eyelids
b. Peripheral edema
c. Dry coarse skin
d. Breathlessness
e. Constipation
f. Weakness
g. Lethargy
h. Fatigue
i. Muscle ache
j. Menstrual abnormality
k. Hair loss
Exclusion Criteria
1)Known case of any chronic and severe systemic disorder including IHD, CVA, uncontrolled Hypertension, uncontrolled diabetes, CRF, Active Malignancy Disease
2)Pregnant and lactating females
3)Known case of congenital hypothyroidism and secondary hypothyroidism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect on level of TSH valueTimepoint: The efficacy of treatment will be assessed on the level of TSH value at baseline and at the end of 90 days
- Secondary Outcome Measures
Name Time Method 1) Effect on subjective parameter on the basis of Billewicz Diagnostic Index and a standard gradation scale. <br/ ><br>2) BMI <br/ ><br>3) Lipid Profile <br/ ><br>4) HemogramTimepoint: The efficacy of treatment will be assessed on the basis of Billewicz Diagnostic Index and a standard gradation scale and BMI at baseline and at the end of 15 days till 90 days. <br/ ><br>Lipid Profile, Hemogram will be assessed at baseline and at the end of 90 days