A Randomized Control Trial Of Vyoshadi Guggulu And Katutumbhi Taila Nasya Along with Levothyroxine In Hypothyroidism w.s.r. Thyroid Stimulating Hormone
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To Evaluate The Efficacy Of Vyoshadi Guggulu and Katutumbhi Taila Nasya
研究概览
简要总结
After clearance of institutional ethics of Government Ayurveda college Nagpur screening of population will be done from patient in OPD, IPD and casualty of our institute. In clinical study of 70 patients of Hypothyroidism will include. If patients fulfill the criteria of inclusion, subject would also given freedom to ask their questions all questions would answer. If he/she agrees for participation in study and found fit to include the patient will include in the study.
The treatment will be given to patient as follow:
Assessment on Zero day
Trial Group :
1.Vyoshadi Guggulu 500 mg BD Before meal for 30 days. 2.Katutumbhi Taila Nasya 8 drops each nostrils for 21 days once in morning .
Control Group :
Tab. Levothyroxine ( directed as per
by Physician )
Assessment on day 15
Assesssment after 30 days
Assessment for the subjective and objective criteria after treatment.
1**.Medium of Dissertation**: The dissertation will be written in English and Sanskrit will be used wherever necessary.
2.Study Design: Randomized Controlled Trial
3.Duration of study: 18 months.
4.Duration of Treatment: 30 days
5.Ethical Clearance: Clearance from Institutional Ethics committee of our institute.
6.Study setting :OPD, IPD and casualty of our institute and its periphery.
7.Duration Of study:Study will start after approval of synopsis from BORS till the completion of sample size. Maximum expected duration is 18 Months.
Subjective and Objective parameters will be considered to evaluate the effect. For this following parameter will be measured. A) OBJECTIVE CRITERIA :
A] ANTHROPOMETRIC CHARACTERS
-
Weight
-
Height
-
BMI
B] CLINICAL PARAMETERS:
-
Blood Pressure
-
Pulse rate
-
Respiratory Rate
-
Spo2
-
Temperature
B) Biochemical parameters:
1.Thyroid Function Test (T3, T4, TSH)
IF Necessary, 1.Complete blood count
2.Urine routine and microscopic
3.BSL fasting and post meal.
4.Lipid Profile
B) Subjective Criteria
The assessment of signs and symptoms will be carried out by following scales.
1.Zulewsk’s Clinical score of Hypothyroidism on 0 th day 15 th day and 30 th day.
Study Population:
1.All the patients attending OPD, IPD and Casualty of our institute will be
considered in this study.
-
Patients in between age group of 18 – 60 years.
-
Patient fulfilling the diagnosatic criteria
Sample Size :
It is estimated based on efficacy of Vysohadhi Gugglu and Katutumbhi Taila Nasya with Levothyroxine reported in published article “A comparative clinical study on the efficacy of Nityanand Ras with (or) without Jeernakarkaruka
Nasya in Hypothyroidism†with following assumptions.
-
% effect of Vysohadhi Gugglu and Katutumbhi Taila Nasya= 51.5%
-
% effect of Levothyroxine = 47.22%
-
Power (1-β)% = 80
-
α-error = 10
-
Required sample size in each group is 32. Considering 10% dropout/non- response, Hence Final sample size is 35 per group.
A.In Trial Group-Vyoshadi guggulu and Katutumbhi Taila Nasya with
Levothyroxine .
B.In Control Group-Levothyroxine
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient on TSH value above 5 mIu/L Patient having clinical features of hypothyroidism and fulfilling diagnostic criteria of this study Patients who are willing to participate in trial and ready to give written consent Patients of either sex aged between 18-60 years irrespective of caste religion socioeconomic and educational status Patient with controlled HTN BP Systolic less than 150 and Diastolic less than90 mmHg and DM having FBS more than 130 mg/dl and PMBS more than 200 mg/dl Patients who are fulfilling the criteria of clinical hypothyroidism score more than 5 according to Zulewsks scale Patient fit for Nasya karma.
排除标准
- •Patients who are suffering from Congenital Hypothyroidism Neoplasia Toxic Goitre Patients who had undergone any type of Thyroid surgery Patients who are not willing to participate in trial and not ready to give written consent Patients having age below 18 years and above 60 years Pregnant women and Lactating mother Patients on prolonged medication more than 6 week with corticosteroids or any drug that may had an influence on the outcome of study Patients who are currently participating in any other clinical trial from last 6 months Patients who has uncontrolled HTN BP Systolic more than 150 Diastolic more than 90 mmHg DM FBS more than 130 mg/dl and PMBS more than 200 mg/dl or any other systemic illness Patient Unfit for Nasya Karma.
结局指标
主要结局
To Evaluate The Efficacy Of Vyoshadi Guggulu and Katutumbhi Taila Nasya
时间窗: On 0th day ,15 th day ,30 th day
Along With Levothyroxine In The Management of Hypo - thyriodism w.s.r Thyriod Stimuting Hormone Levels over 30 days of time span.
时间窗: On 0th day ,15 th day ,30 th day
次要结局
- 1. To evaluate the efficacy of Vyoshadi Guggulu & Katutumbhi Taila Nasya along with levothyroxine in Hypothyriodism on Zulwesk’s scale.(2. To Study Hypothyroidism & its Ayurvedic perspective over 18 months.)
研究者
Pallavi Vasant Valvi
Government Ayurveda College And Hospital Nagpur