Effect of Laghu-vaishvanar Churna and Dhanya Nagar kwath in management of Sublinical Hypothyroidism

Phase 2/3

Not yet recruiting

Conditions: Hypothyroidism, unspecified. Ayurveda Condition: SITAGNITAÂ (AGNIMANDYAM)Â (KEVALA-KAPHA),

Registration Number: CTRI/2022/04/041744

Lead Sponsor: Ayurvedic and Unani Tibbia College Hospital

Brief Summary: INTRODUCTION

Hypothyroidism is a very common disease in human beings. It is a clinical syndrome due to deficiency of thyroid hormones, which result in a generalized slowing down of metabolic process. Hypothyroidism is one of the major disease of thyroid gland involving most of the system of the body. Subclinical hypothyroidism is defined as mildly reduced function of thyroid gland with either minimal symptoms or no symptoms of hypothyroidism having an elevated serum TSH (Thyroid stimulating hormone) level and normal concentration of free T3(Triiodothyronine)FT3, free T4(Thyroxine)FT4, T3 and T4. Although this definition is based on biochemical criteria. It is well recognized that some individual patients may present with symptoms and sign of hypothyroidism. It is confirmed by laboratory diagnosis of serum levels of elevated TSH and normal FT4 and T3. Antithyroid antibodies can be detected in 80% of patient with subclinical hypothyroidism. Positive thyroid antibody titers suggest autoimmune

thyroid disease. Euthyroid patient with positive thyroid peroxidase antibody (TPO) titers have high chance of developing hypothyroidism. It is usually primary disease of thyroid but may be secondary due to disturbances of hypothalamic-pituitary axis.

In Ayurveda, there is no exact mentioned of the disease but it could be correlated with Kaphaja Shotha, Kaphaja Galganda and Rasaja Pradoshaja vikar described by the Acharya. In the Charak Samhita eight type of nindita purusha have been described which can be taken as functional disorders of endocrine. As per the concept of Agni, normalcy of Agni is must for body function rhythmicity. In Ayurveda texts it is mentioned that metabolic process is controlled by Jatharagni, Bhutagni, Dhatvagni. So, the cause of disease is alteration in metabolic activity which according to Ayurveda, is vitiation of Dhatvagni. Agnimandhya at any level due to kaphakara nidan results increased dhatugat mala sanchay, resulting in srotorodh causing compromised dhatu saras, leading to both physical and mental features in subclinical hypothyroidism.

LITERATURE REVIEW -

In Ayurveda there is no direct mention of hypothyroidism. But on the basis of its clinical presentation, it can be correlated with different entities which one explained either as symptoms or disease. So itâ€™s difficult to give a single Ayurvedic term for it. There are many systems which involves in the pathogenesis of hypothyroidism.

On the basis of Ayurvedic principles we can understand the pathology of hypothyroidism. We find that it is basically caused due to dysfunctioning of the Jatharagni (Agnimandhya), which is further leads to Bhutagni and Dhatvagni vitiation, ultimately causing pathological condition of hypothyroidism. This agnimandhya results in formation of abnormal Ras dhatu i.e. Aama lakshna and the symptoms seen in subclinical hypothyroidism are similar.

DRUGS REVIEW:

LAGHU VAISHVANAR CHURNA - The classical preparation is mentioned in Yog Ratnakar.

Its content drugs Saindhav lavan, Haritaki, Pippali, Chitrak mool.

DHANYA-NAGAR KWATH -The classical preparation is mentioned in Yog Ratnakar. Its content drugs Shunthi, Dhanya.

Routine Investigations :

Investigations will be done before starting the therapy and at completion of trial. Assessment of the therapy will be done by evaluating their value before and after completion of trial.

â–ª Haematological investigation-

CBC

ESR

Blood sugar-F and PP,

â–ª Biochemical investigation-

LFT,

KFT,

Urine - routine & microscopy,

Other investigation like ECG, Chest x- ray, USG, CT-scan, MRI, TMT, would be done if necessary.

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Specific Investigations :

1. T3 (Tri-iodothyronine)

2. T4 (Thyroxine)

3. TSH (Thyroid-stimulating hormone)

4. Anti-TPO (Thyroid peroxidase antibody)

PARAMETERS FOR ASSESSMENT OF STUDY OUTCOMES

PRIMARY END POINT

Improvement in subjective symptoms. SECONDARY END POINT

Change in Thyroid profile before and after the study

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patient willing to participate in the trial and sign the consent form.
The patients between the age group of 18 to 60 years in either sex.
Patients of subclinical hypothyroidism with features mentioned in subjective parameters.
On the basis of raised serum TSH(5-10 Î¼IU/ml) and normal serum T4 level.

Exclusion Criteria

Patients who were not willing for trial.
TSH level more than 10 or less than 5 Î¼IU/ml.
Patient with presenting sign of moderate to severe or unmanageable bradycardia (<50bpm) 4.
Patients who are suffering from hypothyroidism for more than 10 year.
Patients suffering from any other systemic illness Diabetes, HTN, liver disorder, tuberculosis etc.
Pregnant and lactating patients.
Patients taking antibiotic therapy for any systemic illness within 2 months.
H/O of hypersensitivity of any trial drug.
Patient who fail to give consent.
Patients with genetic disorder, chronic disorder like paralysis, cancer, renal failure, hepatic failure and IHD.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
8. Menorrhagia (Grade 0-3)	At baseline and at 3 months
Improvement in Subjective parameters	At baseline and at 3 months
4. Constipation (Grade 0-3)	At baseline and at 3 months
2. Dry skin (Grade 0-3)	At baseline and at 3 months
5. Poor apetite (Grade 0-3)	At baseline and at 3 months
10. Weight gain (Grade 0-3)	At baseline and at 3 months
6. Dyspnea (Grade 0-3)	At baseline and at 3 months
7. Hoarse voice (Grade 0-3)	At baseline and at 3 months
1. Weakness (Grade 0-3)	At baseline and at 3 months
3. Feeling cold (Grade 0-3)	At baseline and at 3 months
9. Paraesthesia (Grade 0-3)	At baseline and at 3 months

Secondary Outcome Measures

Name	Time	Method
Changes in Thyroid Profile i.e. T3, T4, TSH values	At baseline and at 3 months

Trial Locations

Locations (1): Ayurvedic and Unani Tibbia College and Hospital
🇮🇳
Central, DELHI, India
Ayurvedic and Unani Tibbia College and Hospital
🇮🇳Central, DELHI, India
Dr Ish Garg
Principal investigator
9958119258
ishgarg4@gmail.com