Effect of Polyherbal formulation in management of hypothyroidism.

Not yet recruiting

Conditions: Other hypothyroidism,

Registration Number: CTRI/2020/10/028181

Lead Sponsor: OPD and IPD of Shree Saptashrungi Ayurved Hospital

Brief Summary: Purpose of the study

Hypothyroidism is posing a major challenge both in developing as well as developed world. It is estimated that about 42 million people suffer from thyroid disorders in India, out of which Hypothyroidism is most common with prevalence of 5.4% 3. Women are affected approximately six times more frequently than men.4 With the changing life style of 21st century Hypothyroidism is considered as one of the commonest endocrinal disorder. Presently the available treatment is oral supplementation of artificially synthesized Levothyroxine with main goal to normalize TSH but not effective symptomatically 5. It has many adverse effects. It requires a systemic and radical therapy for which Ayurveda may provide a ray of hope through Shamana Chikitsa So there is a need of time to have safe and effective Ayurvedic management. Hence an attempt is made to offer effective Poly Herbal formulation in management of hypothyroidism.

AIMS AND OBJECTIVES:

To evaluate the clinical efficacy of New Poly herbal formulation in the management of Hypothyroidism.

PRIMARY OBJECTIVE:

1. To study changes in S.TSH level.

SECONDARY OBJECTIVES:

1. To study improvement in signs & symptoms of Hypothyroidism,

2. To study Hypothyroidism in details with its pathophysiology according to modern and ayuerveda sciences.

3. To study the drugs used in New polyherbal formulation in detail.

HYPOTHESIS:

NULL HYPOTHESIS (H0): New Poly herbal formulation is not effective in management of hypothyroidism.

ALTERNATIVE HYPOTHESIS (H1): New Poly herbal formulation is effective in management of hypothyroidism.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Newly diagnosed cases of Hypothyroidism on the basis of S.
TSH, T3 and T4 levels.
Patients having at least 3 clinical features of Hypothyroidism among Following a )Tiredness/Somnolence b) Unexplained weight gain c) Depression d) Cold intolerance e) Hoarse voice f) Goiter g) Oedema or A puffy face h) Constipation i) Dry skin j) Muscle aches, tenderness and stiffness k) Menstrual irregularity l) Hair loss.

Exclusion Criteria

Patients with.
1. Patient undergoing any known Hormonal Therapy even for thyroid also. 2. Ischemic Heart Diseases, Uncontrolled Hypertension, Uncontrolled Diabetes Mellitus, Myocardial Infarction, Cerebrovascular event, Cardiac Arrhythmias, Pregnancy, Lactating mothers, Active Malignant Disease, Chronicity more than 10 years. 3. Patient age below 18 year and above 60 year of either sex.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether New Ploy Herbal Formulation containing Hamsapadi, Jalkkumbhikshar, Kanchanar,Guduchi,Pimpali, Shigru,Kirattikta is effective in reducing TSH value and signs & symptoms of Hypothyroidism .	Day 0 then 15th then 30th then 60st and 90th

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Shree Saptashrungi Ayurved mahavidyalaya and hospital
🇮🇳
Nashik, MAHARASHTRA, India
Shree Saptashrungi Ayurved mahavidyalaya and hospital
🇮🇳Nashik, MAHARASHTRA, India
Dr Phartale Vaibhav Dattatray
Principal investigator
8605431111
vdphartale2002@gmail.com