Study The Efficacy Of Triphaladya Guggulu As Add-On Therapy With Thyroxine 25 Mcg In Patients Of Hypothyroidism On TSH Level
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduce The Symptoms Of Hypothyroidism.
研究概览
简要总结
OBJECTIVES
Primary Objective:
- To study the add-on effect of Triphaladya Guggulu given along with Thyroxine ,on TSH level .
- To study the effect of Thyroxine on TSH.
- To compare the effect of Triphaladya Guggulu given along with Thyroxine with that of Thyroxine alone in the patient of Hypothyroidism.
Other Objectives
- To review and study the literature of Galganda-Gandmala.
- To review and study the literature of Hypothyroidism.
- Any new theoretical and practical concept if found during study will be noted down
PARTICIPANTS
40 Adults diagnosed with Hypothyroidism meeting inclusion and exclusion criteria from OPD and IPD of department of Kayachikitsa of Shree Saptashrungi Medical College and Hospital Nashik
Interventions
20 patients Oral administration of Triphaladya Guggulu 2 tab BD with Tab Thyroxine 25mcg BD
20 patients Oral administration of Tab Thyroxine 25mcg BD
Outcome : Reduce the sign and symptoms of Hypothyroidism
Treatment Duration : 30 Days Follow Up :0th , 15th , 30th Days
Data Analysis : Data will be analyzed using appropriate statistical methods to compare the effectiveness of the intervention on the primary and secondary outcomes.
Ethical Considerations: The study will be conducted in accordance with ethical guidelines and with informed consent from participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having at least 3 clinical features of Hypothyroidism among following – Symptoms- Tiredness. Dry skin Feeling cold Hairfall Difficulty in concentration and poor memory Weight gain with poor appetite Dyspnea Hoarse voice Impaired hearing. Signs.
- •Dry coarse skin , cool peripheral extremities Puffy face, hands and feets. Diffuse alopecia Bradycardia. Peripheral edema.
排除标准
- •Hypertension Hyperthyroidism Pregnancy Lactation DM IHD Patients undergoing any known hormonal therapy.
- •Malignancy Any surgical pathology.
结局指标
主要结局
Reduce The Symptoms Of Hypothyroidism.
时间窗: 30 days
TSH level before and after will be assessed.
时间窗: 30 days
Following will also be assessed-
时间窗: 30 days
1. tiredness
时间窗: 30 days
2. hair loss by hair pull test
时间窗: 30 days
3. constipation
时间窗: 30 days
4. oedema
时间窗: 30 days
次要结局
- Reduce The Symptoms Of Hypothyroidism like tiredness , hair loss , oedema . BMI will be assessed(30 days)
研究者
Dr Anand Pramod Rahangdale
Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyalaya