1. What data in particular will be shared?
   Response (Others) - 


2. What additional supporting information will be shared?
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response (Others) - 


5. By what mechanism will data be made available?
   Response (Others) - 


6. For how long will this data be available start date provided 08-05-2023 and end date provided 06-05-2028?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - No

RESEARCH QUESTION:

What will be the efficacy of Kanchanar Guggulu in a dose of 500 mg thrice a day and Varunadi Kashaya in a dose of 15 ml twice a day with and without Virechana for a period of two months in the management of Hypothyroidism in adolescents?

HYPOTHESIS:

Null hypothesis (H0): Kanchanar Guggulu and Varunadi Kashaya have equal effects with or without Virechana in the management of Hypothyroidism in adolescents.

Alternative hypothesis (H1): Kanchanar Guggulu and Varunadi Kashaya have more effect with Virechana in the management of Hypothyroidism in adolescents.

NEED OF STUDY:

1.     No studies have been conducted on hypothyroidism in the pediatric age group in Ayurveda.

2.     Thyroid hormones are necessary for the normal functioning of every tissue in the body. Its flaws, therefore, manifest themselves in the involvement of a multisystem. There are no promising therapies to treat hypothyroidism in the contemporary system. The only available treatment is hormone replacement therapy in the form of synthetic thyroxine i.e., Levothyroxine. Treatment of hypothyroidism with synthetic thyroid hormone derivatives can return TSH and T4 levels to the normal range, but increased doses and continued medication leave patients addicted to the drug for the rest of their life. Excessive thyroid hormone replacement has the potential for serious long-term metabolic complications.

3.     Treatment with levothyroxine is associated with an increased risk of cancer, including many types of cancer.⁷  

4.     Patients undergoing long-term T4 replacement are prone to both cardiovascular disease due to dyslipidemia and fracture due to decreased bone density.⁸

5.     In subclinical hypothyroidism, there is a mild elevation in TSH levels can be seen but, in many cases, SH can progress to hypothyroidism.⁹ So in this case Ayurveda plays a vital role in balancing the TSH level and keeping it in normal indices.¹⁰

OBJECTIVES OF THE RESEARCH PROJECT:

The present research trial will be undertaken with the following objectives.

PRIMARY OBJECTIVES:

•       To assess the efficacy of Kanchanar Guggulu in a dose of 500 mg thrice a day and Varunadi Kashaya in a dose of 15 ml twice a day with and without Virechana in adolescents (10-16 years) for a period of two months (60 days) in reducing the level of TSH.

           SECONDARY OBJECTIVES:

•       To assess the efficacy of Kanchanar Guggulu in a dose of 500 mg thrice a day and Varunadi Kashaya in a dose of 15 ml twice a day with and without Virechana in adolescents (10-16 years) for a period of two months (60 days) in the improvement of clinical features of Hypothyroidism.

•       To assess the efficacy of Kanchanar Guggulu in a dose of 500 mg thrice a day and Varunadi Kashaya in a dose of 15 ml twice a day with and without Virechana adolescents (10-16 years) for a period of two months (60 days) in tappering the dose of levothyroxine.

•       To assess the efficacy of Kanchanar Guggulu in a dose of 500 mg thrice a day and Varunadi Kashaya in a dose of 15 ml twice a day with and without Virechana in adolescents (10-16 years) for a period of two months (60 days) in Zulewski clinical score.

METHODOLOGY:

Adolescents will be selected from the OPD age group between 10 -16 years. The patients coming under the inclusion criteria of the study and their parents will be counselled and informed about the treatment plan. Those who are willing to undergo the therapy and ready to submit informed consent shall be recruited for the proposed clinical study. The proposed study design is depicted in the graphical tree to follow.  The patients who are on levothyroxine will be asked to reduce the dose gradually and 7 days before the commencement of the study, it will be completely withdrawn.

CLINICAL STUDY:  

INCLUSION CRITERIA:  

1.     Individuals of either gender between the age group of 10 - 16 years. 

2.     Diagnosed cases/new cases of hypothyroidism on the basis of Sr. TSH, T3, and T4 levels.

1. Subclinical hypothyroidism- 5-10µIU/ml with minimal or absence of symptoms
2. Clinical hypothyroidism- > 5 µIU/ml with clinical symptoms

3.     Parents giving consent to participate in the study. 

EXCLUSION CRITERIA: 

1.     Recent thyroid surgery or radioiodine therapy within 1-year of the study’s start date. 

2.     History or presence of clinically relevant cardiovascular, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease or malignant tumor, hereditary diseases, or syndromes. 

3.     Severe mental disorder. 

4.     Recent hospitalization for a major illness or elective surgery within 1-year of the study’s start date

5.     Diabetes mellitus type-1 patients. 

6.     Patient/Parents not willing to participate in the study. 

CRITERIA FOR DIAGNOSIS:  

1) Sr. TSH, T3 and T4 levels

•       Subclinical hypothyroidism- 5-10µIU/ml with minimal or absence of symptoms

•       Clinical hypothyroidism- > 5 µIU/ml with clinical symptoms

•       Total Sr. T4 level with normal value (Total Sr. T4 = 4.2 to 13.00 µg/dl) 

•       Total Sr. T3 level with normal value (Total Sr. T3 = 80 to 210 ng/dl)

INVESTIGATIONS: 

The following laboratory investigations will be done before and after treatment. 

•       Thyroid Profile

•       Lipid Profile

•       Anti-TPO (thyroid peroxidase)- BT (to rule out autoimmune cases)

GROUPING: 

4 GROUPS:  

Part-A (Subclinical Hypothyroidism)

Trial-A – Kanchanar Guggulu and Varunadi Kashaya with or without Virechana

Control-A- Kanchanar Guggulu and Varunadi Kashaya

Part-B (Clinical Hypothyroidism)

Trial-B- Kanchanar Guggulu and Varunadi Kashaya with or without Virechana

Control-B- Kanchanar Guggulu and Varunadi Kashaya

DRUG DELIVERY REGIMEN:

Duration: 60 days

Follow-up: 60 days

CRITERIA FOR ASSESSMENT:

•                Thyroid profile

•                Clinical features (annexure-1)

•                Zulewski clinical score (annexure-2)

STATISTICAL METHODS FOR ANALYSIS:  

Statistical test:

Part-A: On the basis of the TSH variable, within the group, paired t-test and between the group Z-test will be used. For subjective data, Wilcoxon signed rank will be used.

Part-B: On the basis of the TSH variable, within the group, paired t-test and between the group unpaired t-test will be used. For subjective data, Wilcoxon signed rank will be used.

SPSS (V-26) will be used for data analysis