Open labelled comparative clinical Study of ayurveda treatement protocol with thyroxine in Hypothyroidism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 1. To develop a protocol for Ayurvedic management of Hypothyroidism.
Study Overview
Brief Summary
The Modern system of medicine is still exploring medicine for better and more effective management of hypothyroidism synthetic thyroid hormone derivatives may bring the value of thyroid stimulating hormone (TSH) and T4 to normal range, but the increased dosage and continuous medicine make the patient drug dependent till the end of life .
The purpose of the study is to develop a protocol for the ayurvedic management of Hypothyroidism in terms of alleviation of sign and symptoms and to maintain serum concentration of T3, T4 without rise in serum TSH at normal level.Hypothyroidism is a commonly prevailing disorder in adult Indian population .It is estimated that about 42 million people suffer from thyroid disorder in India , of which hypothyroidism is most common with a prevalence of 5.4%4.Hence this topic is selected to study the trial drug Shaddharana Churna is a polyherbal formulation which act on rasa dushti ,kapha dusti. It causes Aampachan so that Jatharagnideepna and Dhatwagnideepna will be achieved In this way all the contents of Shaddharana churna helps to break the above Samprapti of Hypothyroidism by correcting dysfunction of Agni.In hypothyroidism the main pathology is present in thyroid gland, which is situated in the Urdhvajatru. Pratimarsha Nasya of Nirgundi Taila is choosen for Nasya Karma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •newly diagnosed subject who are not on any medications and willing to take ayurvedic treatment already diagnosed subject who are under thyroxin medicine and willing to take ayurvedic medications subjects having serum TSH leval more than 4.5 micro international units per ml.
Exclusion Criteria
- •Congenital hypothyroidism or anatomical deformity related to thyroid gland.
- •Rapid progressive cases of Myxoedema.
- •Pregnancy and Lactation.
- •Individual with ischemic heart diseases, uncontrolled hypertension, myocardial infarction,cerebrovascular event, cardiac arrhythmias, active malignant disease, patient having PCOD or other hormonal disturbance excluded from study.
Outcomes
Primary Outcomes
1. To develop a protocol for Ayurvedic management of Hypothyroidism.
Time Frame: 90 days
2.To assess effect on different clinical parameters such as Peripheral edema, Dry and coarse skin, Breathlessness, constipation, Lethargy, Hair loss, Weight gain in Hypothyroidism.
Time Frame: 90 days
3.To assess the effect on changes in Thyroid profile.
Time Frame: 90 days
Secondary Outcomes
- 1. To develop a protocol for Ayurvedic management of Hypothyroidism.
Investigators
Dr Krutika Rajendra Hupare
10 Kayachikista Department Seth Sakharam Nemchand Jain Ayurveda Rugnalaya 118/119 shukrawar peth near juni faujdar chawdi Solapur MAHARASHTRA 413002 India