An Open Randamised Controlled Clinical study to evaluate the efficacy of Varunadi gutika as an adjuvant therapy with levothyroxine in the management of Primary Hypothyroidism
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To study the effect of ‘Varunadi Gutika’ As an adjuvant therapy with
研究概览
简要总结
Ayurveda is one of the ancient health care system. Ayurveda promotes specific lifestyle changes and natural treatments to restore harmony between the body, mind, spirit, and environment. Ayurveda is a holistic tradition and way of life that can assist each of us In claiming and celebrating our ability for wellness. The guiding principles of Ayurveda, maintaining health in all situations and eras, justifies current requirements for past uses. Due to an increase in sedentary and unhealthy lifestyles, many people nowadays
experience numerous metabolic problems, including primary hypothyroidism. Hypothyroidism is one of the burning issue now a days. An unusually low thyroid hormone level is one of the symptoms of hypothyroidism. It happens when the thyroid gland does not produce enough thyroxine. Each organ in the body may be impacted by thyroxine’s control over how the body uses energy. Thyroxine deficiency causes the body’s functions to slow down. It affects nearly every bodily function, therefore maintaining a healthy level of thyroid hormone is essential for good health. The prevalence rate of hypothyroidism in Mumbai is 9.45%. Thyroid disease affects women more often than men and affects roughly 5% of the population. Womens are affected approximately six time more frequently than men. Ayurveda states that the pathophysiology of hypothyroidism is mostly caused by agni’s improper activity. It can be correlated to the concept of mandagni in ayurveda. The pathogenesis process is eventually shown by abnormal jatharagni functioning, which then affects dhatwagni and, ultimately, results in the disease condition.
Varunadi Gutika is a combination of 09 drugs, which are Varun, Bruhati, Kanthakari, Chitrak, Bilva, Shobhanjan, Shatavari, saireyak, karanja. All these drugs have Ushna, Tikshna, Deepana, Pachana and Grahi properties therefore it will reduce the symptoms of hypothyroidism comparing to ’mandagni’
Need of study:
For the treatment of primary hypothyroidism, an efficient pharmaceutical preparation is required. As the hormone replacement therapy is only available way to treat the condition. There is flaw in this conventional treatment because it required prolonged use. With the chronicity of the disease, the gland functioning never improves, instead they become more and more inactive. Taking above in consideration, I have chosen my synopsis under title, “An Open Randomised Controlled Clinical Study to evaluate the efficacy of Varunaadi gutika as an adjuvant therapy with Levothyroxine in the management of primary hypothyroidism."
Number of patient-
Group A: Study group -30 patient will be administered Varunadi gutika along with
Levothyroxine.
Group B: Control group-30 patient will receive only Levothyroxine.
Investigations-
CBC, ESR, BSL fasting and PP, Liver Function and Renal Function Test, Lipid Profile to exclude any Pathology.
Thyroid function test , BSL and Lipid profile will be estimated before and after treatment.
Summary and Conclusion:
The work will be summarized to make final conclusions Observations of results will be concluded with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole research.
Expected outcomes:
• Changes in subjectives by ’Varunadi Gutika’ towards reduction in previous severity.
• Changes in Thyroid profile by ’Varunadii Gutika’ towards reduction of Sr.TSH in previous high levels.
• Effect of ’Varunadi Gutika’ could be more than the effect of Tab.Levothyroxine without any adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Signs and symptoms of primary hypothyroidism- gauravata, nidradhikya, agnimandya, Shram, khalitya.
- •Subjects who are willing to give written informed consent.
- •Serum T3 and T4 within normal range and Serum TSH level above 5.5µU/ml but below 20 µU/ml.
排除标准
- •Secondary hypothyroidism, itrogenic hypothyroidism, post thyroidectomy.
- •Pregnant & lactating mothers 3)Uncontrolled Hypertension, Diabetes Mellitus, IHD, CVA.
- •Malignancy of Thyroid Gland 5)Any other metabolic or systemic disease conditions where other treatment is urgent and was disturb the regimen.
- •(HIV, Diabetes Cardiovascular disease, Tuberculosis etc.) 6)Patient having myxoedema coma.
- •Patients having Down’s syndrome, Turner’s syndrome, Klinefelter’sSyndrome will be excluded.
- •Present history of any mental disorder.
- •Patient with acute and chronic gastritis, PR bleeding.
结局指标
主要结局
1.To study the effect of ‘Varunadi Gutika’ As an adjuvant therapy with
时间窗: For 3 months
levothyroxine on Kshudhamandya (poor appetite), Malavstambha(constipation),
时间窗: For 3 months
Shram(lethargy), gauravta (heavyness of the body), Khalitya (hairloss), Nidradhikya
时间窗: For 3 months
(increased sleep), etc. symptoms of primary hypothyroidism.
时间窗: For 3 months
2.To study the effect of Varunadi Gutika as an adjuvant therapy with levothyroxine
时间窗: For 3 months
on serum TSH T3, T4 level
时间窗: For 3 months
次要结局
- 1)To review the Ayurvedic & Modern literature on Primary Hypothyroidism.(2)To correlate Rasdhatvagnimandya,Rasapradoshjanya vyadhi & Primary Hypothyroidism.)
研究者
Dr Pranay Omprakash Gundewar
R.A. Podar hospital, worli