Clinical study of Ayurvedic medicines namely â€˜Vyoshadi Gugguluâ€™ and â€˜Shadushana Churnaâ€™ in the management of subclinical hypothyroidism

Phase 2

Not yet recruiting

Conditions: Subclinical iodine-deficiency hypothyroidism,

Registration Number: CTRI/2019/05/018989

Lead Sponsor: National Institute of Ayurveda

Brief Summary: Sub Clinical Hypothyroidism (SCH) is defined as mildly reduced function of thyroid gland with either minimal symptoms or no symptoms of hypothyroidism having an elevated serum TSH level and normal concentrations of free T3 (FT3), free T4 (FT4), T3 and T41,2. Although this definition is based solely on biochemical criteria, it is well recognized that some individual patients may present with symptoms and signs of hypothyroidism3,4,5,6. A large cross-sectional study confirmed that participants with subclinical hypothyroidism reported more symptoms than euthyroid individuals, but fewer symptoms than overtly hypothyroid participants and did not distinguish between untreated subclinical hypothyroidism and undertreated overt hypothyroidism7. Edema, generalized pain, anorexia, constipation, dry/ coarse skin, excessive sleep, menstrual irregularities, fatigue, are among the most common symptoms. It is confirmed by laboratory diagnosis of serum picture of elevated thyroid stimulating hormone (TSH) and normal serum concentration of free thyroxin (FT4) and total Triiodothyronine (T3)8.Antithyroid antibodies can be detected in 80% of patients with Subclinical hypothyroidism, and 80% of patients with Subclinical hypothyroidism have a serum TSH of less than 10 mIU/L. The risk of subclinical hypothyroidism turning into overt hypothyroidism is higher if any of the following persists i.e. symptoms, enlarged thyroid, thyroid antibodies detected in a blood test and female patient.

There is no direct mention of Thyroid gland and Hypothyroidism in Ayurveda. However, a disease named *galaganda*, characterized by neck swelling is well known. Acharya charaka has included it under 20 *shleshma vikara9*. Thyroid hormone functions are similar to the functions of *agni (jatharagni, dhatvagni and bhootagni*) in our body causing transformations / tissue metabolism at various levels and thus maintaining the BMR. *Agnimandya* at any level due to *kaphakara nidana* results in increased *dhatugata mala sanchaya,* resulting in *srotorodha* causing compromised *dhatu - sara* leading to both physical and mental features in subclinical hypothyroidim. as swelling, anemia, constipation, cold intolerance etc This *agnimandya* results in formation of abnormal *rasa dhatu (apachita rasa dhatu*) i.e. *ama10. Ama lakshana* and the symptoms seen in subclinical hypothyroidism are similar.

The line of treatment of *ama dosha* revolves around *pachana* (digestion of *ama)* then *deepana (*igniting digestive fire) and lastly *shodhana* after *snehana & swedana karma*. The *shodhana* karma is strictly contraindicated in first place since *ama dosha i*s not localised. *shodhana* without *ama pachana* results in further complication as *ama dosha* is amalgamated with body tissues. The therapy focuses on *pachana* (digestion of existing *Aamadosha*), *deepana (*increasing digestive power)*, anulomana* (purge) and *shamana* (medicine) to avoid further formation of *Ama1*1. *Vyoshadi guggulu (Brihat Nighantu Ratanakar*) and *Shadushana churna (Bhavaprakash)* have been selected to manage subclinical hypothyroidism. It is indicated in *arochaka* (tastelessness), *agnimandya* (digestive impairment), *ama dosha* (products of impaired digestion and metabolism / consequences of *ama),* *galaroga* (diseases of throat, *sthaulya* (obesity). Therefore it helps in alleviating the associated features of subclinical hypothyroidism.

PREVALENCE

Subclinical Hypothyroidism (SCH) or mild thyroid failure is more prevalent in recent years and is causing major controversies concerning management and treatment. The Wickham study, an extensive population-based survey, the prevalence of Sub Clinical Hypothyroidism is 7.5% in women and 2.8% in men12. The highest prevalence (upto16%) was found in elderly women over 60 years of age13. It is more prominent in females rather than males14.

IMPORTANCE OF PRESENT STUDY

As far as modern medicine is concerned, benefits of treatment need to be weighed against any potential risks. The clinical importance of and therapy for mild elevation of serum TSH (<10 mIU/L)15 and the exact upper limit of normal for the serum TSH level remain subjects of debate16. When the TSH level is above 10 mIU/L levothyroxine therapy is generally agreed to be appropriate17. However, management of patients with a serum TSH level of less than 10 mIU/L is controversial. The arguments against treatment are its expense and the likelihood that some patients will not benefit. There is also a danger of over-treatment, which could cause iatrogenic hyperthyroidism. Management of hypothyroidism with the modern drugs may bring the value of TSH and T4 to normal range but the increased dosage and continuous medication make the patient drug dependent till the end of mortal life. Although Levothyroxine is a mostly used in Hypothyroidism but it has some limitations and side effects as extreme fatigue, fever, irregular breathing etc. 30% of the subclinical cases will progress to overt hypothyroidism, 30% revert back to euthyroidism, 40% remains in subclinical hypothyroidism. So, vyoshadi guggulu and shadushana churna having its effect on agni (a root cause of sub clinical hypothyroidism) are expected to prevent overt hypothyroidism and will revert back subclinical stage to euthyroid. So, a better, safer and long lasting therapy is needed for the present society and now it is a demand of time to search the management for this type of ailment through the heritage of Ayurveda. Keeping this fact in mind, the clinical trial is proposed after compiling all available references from classical authentic texts.

SELECTION OF DRUG

The main factor responsible for the manifestations of hypothyroidism is the *agnimandya,* hence drugs acting on agni, having *deepana*, *pachana, srotoshodhaka, medohara, lekhana* properties are likely to check the basic pathogenesis of hypothyroidism. Among the wide varieties of drugs mentioned in Ayurveda text books *vyoshadi guggulu* and *shadushana churna* has been chosen for the study so as to establish its efficacy in successful treatment of hypothyroidism. Contents of *vyoshadi guggulu* and *shadushana churna* having *deepana* and *pachana* properties, administration of these drugs checks control *agnimandya.* The contents of this drug are easily available and very effective.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

1.Newly diagnosed patients of TSH level 5-10 mlU/l.
2.Patients having any signs and symptoms of subclinical hypothyroidism.
3.Patients willing to participate in the study.

Exclusion Criteria

1.Patients below 18 years and above 60 years of age.
2.TSH level more than 10 or less than 5.
3.Patients under allopathic treatment for Subclinical or clinical hypothyroidism.
4.Patients suffering from any other systemic illness viz.
diabetes, HTN, liver disorders etc.
6.Patients undergoing treatment for any other systemic illness.
7.Patient participated in any clinical trial within last six months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any changes in the values of Serum TSH.	60 days

Secondary Outcome Measures

Name	Time	Method
Changes in specific symptoms of subclinical hypothyroidism.	60 days

Trial Locations

Locations (1): National Institute of Ayurveda, Hospital
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda, Hospital
🇮🇳Jaipur, RAJASTHAN, India
Dr Vidhya Bharti Sharma
Principal investigator
9462557647
vidyabs21@gmail.com