A Clinical pilot study to evaluate effect of Nano Kanchanara Twak extract Capsule (Ayurvedic Medicine) in Hypothyroidism patients

Phase 2

Not yet recruiting

Conditions: Hypothyroidism, unspecified. Ayurveda Condition: SVAYATHUH/SOTHAH/SOPAH,

Registration Number: CTRI/2022/05/042402

Lead Sponsor: Dean Faculty Of Ayurved

Brief Summary: Hypothyroidism is a hypo-metabolic clinical stateresulting from inadequate production of thyroid hormone for prolonged period orrarely, from resistance of the peripheral tissue to the effect of thyroidhormones. Primary hypothyroidism is a dysfunction in the thyroid gland and,it can be sub-clinical or overt. Due to easily stimuli like stress and anxiety, the global incidence of hypothyroidism is increasing. Kanchanara reduce the swelling of neck, increased serum thyroid hormoneconcentration, decreased cholesterol and improve thyroid histology. Kanchanara stem bark has been investigated and reported tohave anti-tumor property. Kanchanara extract, as standardized extracts, provide unlimited opportunitiesfor uncovering new drug because of the innumerable availability of chemical composition. Prevalence rate of Hypothyroidism in developed countries is 4.6% . Where as inIndia it is 10.95%. Incidence rate of hypothyroidism is more infemales (15.86%) than males (5.02%). Lacunas in current management. HRT is the single available treatment& Long-term metabolic complications of HRT. Increaseddosage and continuous medication make the patient drug dependent tillthe end of the life. So therefore need to find new drug which willprevents further lacunas hence extraction of Kanchanar Twak willhelp to concentrate the chemical constituent in a soluble form and by using Nanotechnology we will able to level up herbs bioavailability,effectiveness and also able to reintroduce other component that were discardeddue to poor characteristics.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 12

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 Î¼IU/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.
Muscle ache j.
Menstrual abnormality k.

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 value	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.	2) BMI

Trial Locations

Locations (1): Parul Institute Of Ayurved
🇮🇳
Vadodara, GUJARAT, India
Parul Institute Of Ayurved
🇮🇳Vadodara, GUJARAT, India
Dr Yakshi Choudhary
Principal investigator
7983254783
yakshichoudhary@gmail.com