a clinical comparative study to evaluate the efficacy of kanchnar guggulu vatika and hamsapadiadi kashaya in the management of avatu granthi vikar w.s.r. hypothyroidism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduce the associated symptoms of Avatu Granthi Vikar (Hypothyroidism)
研究概览
简要总结
Acharya Charaka categorize Hypothyroidism in Anukta Vyadhies means any disease which is not explained in Ayurvedic text but studied and treated on the basis of Kupit Dosha, Hetu, and their Sthan. The term Hypothyroidism is not mentioned directly in Ayurvedic texts, but the problems related to Thyroid Disorders were well described under the disorder known as Galaganda (Enlarged thyroid gland).
An analysis of the symptomatology of hypothyroidism, in the light of the Ayurvedic principle of Doshas & Dushya, showed in the Hypothyroidism there is a hypo activity of Agni at Koshta and Dhatu level with the analysis of symptomatology of Hypothyroidism there’s a vatiation of Kapha-Vata Doshas . The lakshanas depend on the extent of involvement of Dhatus. So, the fundamental treatment principle in Hypothyroidism is to restore the Karmukata of Agni at both Kostha and Dhatu levels. This can be achieved through Ama Pachanam, Agni Deepanam, Srotosodhanam and administration of appropriate Rasayanam. Here Agni becomes diminished at the level of Dhatus and Sanga srotas which results in impairment of Dhatu function and leads to the symptoms as seen in hypothyroidism.[ By keeping all these things in my minds the select drugs will be fruitful in effective management of the disease rectifying Agnimandhya and Kapha-Medo dushti.
The volunteers will be informed about the study protocol and willing participants will be randomly selected as per the coin method. Clinical research format will be prepared and validated before the study approval will be taken from the IEC of the Shri NPA Govt. Ayurved College and hospital, Raipur C.G. and CTRI registration will be done. After selection, each participant will be tasted individually and selected according to the assessment criteria. Sixty patients of Avatu Granthi Vikar will be selected from Kayachikitsa OPD and IPD Shrihri NPA government Ayurved college and hospital, Raipur C.G. The
case selection was in regards to age, sex, occupation, and socio-economic conditions. Both acute and chronic phases of Avatu Granthi Vikar patients were taken for the study, following the WHO scoring of Ayurveda Symptoms’s criteria for diagnosing Avatu Granthi Vikar as well as the clinical features of Hypothyroidism described in modern medicine. The present study is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60 clinically diagnosed and registered patients of Hypothyroidism were divided randomly by coin method into three groups. Each group will have 20 patients. Group A: 20 clinically diagnosed patients of Hypothyroidism will be treated with Kanchnar Guggulu Vatika 2 tablets (each 500 mg) two times in a day with lukewarm water before meal for 90 days. Group B: 20 clinically diagnosed patients of Hypothyroidism were treated with Hmasapadiadi Kashaya 40 ml two times in a day before meal with anupana madhu for 90 days along. Group C: 20 patients diagnosed with Avatu Granthi Vikar were treated with both trial drugs Kanchnar Guggulu Vatika (2Tab) and Hamsapadiadi Kashaya (40ml) two times a day before meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •It is based on clinical signs and symptoms mentioned in modern and ayurvedic classics, especially loss of appetite, puffiness, constipation, weight gain with the help of WHO Scoring of Ayurveda Symptoms.
排除标准
- •1.Patients below 18 years & above 60 years of age will not be taken.
- •Pregnancy & lactating mother.
- •TSH level more than
- •T3 and T4 level are lower tahn normal.
- •Patients with a prior history of head and neck radiation.
- •patients having Hypothyroidism with complications.
- •Patients undergoing any known hormonal therapy.
- •The patients underwent any thyroid surgery or had an already diagnosed case of carcinoma.
- •Patients with long-term steroid treatment.
- •Recent participation in other clinical trial.
- •Severe mental disorder.
- •History of hypersensitivity to any of the trials and their ingredients.
结局指标
主要结局
reduce the associated symptoms of Avatu Granthi Vikar (Hypothyroidism)
时间窗: reduce the associated symptoms of Avatu Granthi Vikar in 8 weeks.
次要结局
- Improve the quality of life(90 Days)
研究者
VANDANA SIDAR
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh
