EFFECT OF SHATPUSHPA CHURNA, DHANYAK SHUNTHI PANIYA AND AYURVEDIC DIETARY AND LIFESTYLE MODIFICATION IN MANDAGNI WITH SPECIAL REFERENCE TO SUBCLNICAL HYPOTHYROIDISM.

Phase 2/3

Completed

• Conditions: Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: MANDAGNIH/Â AGNISADA,

• Registration Number: CTRI/2022/04/041594
• Lead Sponsor: NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR

Brief Summary

Subclinical hypothyroidism (SCH) is biochemically defined as an elevated level of thyroid stimulating hormone (TSH) with normal level of free thyroxine (FT4) in the blood with minimal or no signs and symptoms of thyroid dysfunction. The most common cause of subclinical hypothyroidism is chronic autoimmune thyroiditis associated with antithyroid peroxidase antibodies (Hashimoto’s thyroiditis) but it can also occur due to other causes. Subclinical hypothyroidism can be classified as Mild Grade 1 SCH (upper limit of TSH 9.9 mIU/L) and severe grade 2 SCH (TSH ≥10mIU/L). Individuals with subclinical hypothyroidism are often asymptomatic, but clinical manifestations similar to overt hypothyroidism are present in milder form. Several meta-analyses of observational studies have revealed an association between SCH and coronary artery diseases.

There is no direct description of hypothyroidism or subclinical hypothyroidism  in Ayurvedic texts. There are many diseases which are not mentioned directly in Ayurveda texts and are called as *Anukta vikar*. Subclinical hypothyroidism is one of such disease. According to *Acharya Charak,*  it is not possible to name every disease but it is important to understand the possible pathogenesis of the disease in terms *of Dosha, Dhatu, Mala & Agni* because the vitiated *Doshas d*ue to difference in *Nidana* give rise to different disease at different places. Therefore, if a physician understands the *Prakriti, Adhishthan and Samuthan vishesha* of the disease it can be managed successfully.

On reviewing literature on SCH**,** it has been found that Subclinical Hypothyroidism in Ayurveda has been correlated with terms like *Agnimandhya*, *Dhatwaagnimandhya, Raspradoshajvikara and Avranjanya vikara,* the root cause of all these disorders being abnormality of *Agni.* However, there is a lack of scientific studies establishing an association of status of *Agni* and SCH.  With all these points in mind the current study has been planned with an aim to estimate the prevalence of *Agnivaishamya* in patients with Subclinical hypothyroidism and to study the effect of *Agnideepan* *chikitsa* in patients of Subclinical hypothyroidism with *Mandagni.*

In this study patients of subclinical hypothyroidism will be interviewed and an assessment of *Agni* will be done using *Agni* assessment questionnaire and Patients of subclinical hypothyroidism with *Mandagn*i will be enrolled to study the effect *of Shatpushpa Churna*, *Dhanyak Shunthi Paniya* and *Nidana Parivarjana* on TSH level and symptoms *of Mandagani.*

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Study Completion: 2023-07-15
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Patients between the age of 18-60 years of either sex. 2.Patients with subclinical hypothyroidism with TSH levels ranging from 5.5µIU/ml.
• 20µIU/ml. 3. k/c/o Subclinical Hypothyroidism but still not taking Levothyroxine therapy. 4.Patients willing to take Ayurvedic medicine and sign the consent form. 5.Patients having symptoms of Mandagni.

Exclusion Criteria

• 1.TSH level above 20 µIU/ml.
• 2.Patients already under Levothyroxine therapy.
• 3.Patients suffering from congenital hypothyroidism, overt hypothyroidism, and secondary hypothyroidism.
• 4.Patients of hyperthyroidism, neoplasia, toxic goitre are excluded.
• 5.Patients who have undergone any type of thyroid surgery.
• 6.Patients suffering from systemic diseases like cardiac problems, diabetes, carcinomas etc.
• 7.Patients taking drugs known to alter thyroid hormone level (e.g., Amiodarone) 8.Patients who are pregnant or expecting pregnancy in next six months.
• 9.Recent hospitalization for major illness, to exclude with ESS (Euthyroid Sick Syndrome).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in TSH value	60 DAYS

Secondary Outcome Measures

Name	Time	Method
Change in the symptoms of Mandagni	Change in general sign and symptoms associated with subclinical hypothyroidism.

Trial Locations

Locations (1)

NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR; 🇮🇳 Jaipur, RAJASTHAN, India

NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR

🇮🇳Jaipur, RAJASTHAN, India

DR DEEP MALA

Principal investigator

7018659647

deep.choba24@gmail.com