Effect of Kanchanar Guggulu and Varunadi Kashaya with and without Virechana in the Management of Hypothyroidism in Adolescents
- Conditions
- Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH,
- Registration Number
- CTRI/2023/03/051020
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
**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 of15 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 of15 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 of15 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 of15 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 of15 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:**
| | |
| --- | --- |
|Study type
Interventional
|Purpose
Treatment
|Masking
Open-label
|Randomization
Block Randomized-Permutated
|Control
Controlled
|Timing
Prospective
|End Point
Efficacy
|No. of groups
Four (Part-A Two groups and Part-B Two groups)
|Sample size
55 in subclinical hypothyroidism and
31in clinical hypothyroidism
**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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 150
- 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. a.Subclinical hypothyroidism- 5-10µIU/ml with minimal or absence of symptoms b.Clinical hypothyroidism- > 5 µIU/ml with clinical symptoms 3.Parents giving consent to participate in the study.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To assess the efficacy in reducing the level of TSH. 0th day, 15th day, 60th day and 120th day
- Secondary Outcome Measures
Name Time Method •To assess the efficacy in the improvement of clinical features of Hypothyroidism. •To assess the efficacy in tapering the dose of levothyroxine.
Trial Locations
- Locations (1)
All India Institute of Ayurveda
🇮🇳West, DELHI, India
All India Institute of Ayurveda🇮🇳West, DELHI, IndiaDr Bhimrao MeshramPrincipal investigator9766818159meshram20bhimrao@gmail.com