A Randomised Comparative Clinical Study To Evaluate The Efficacy Of Gomutra Bhavit Jalkumbhi Bhasma And KPG Vati With And Without Ujjayi Pranayama In Cases Of Hypothyroidism.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical outcome assessment among the people registered under the study will be done through -
研究概览
简要总结
AIM & OBJECTIVES-
a. To assess the probable mode of action of ayurvedic drugalong with Ujjayi Pranayama combination in the management of theHypothyroidism.
b. Toassess the effectiveness of trial drug in the cases of Hypothyroidism.
c. Tonormalize the levels of TSH in the mild cases.
d. To assessthe effect of the trial drug on resistant cases of levothyroxine.
e. Togradually replace the hormone (levothyroxine) with the trial drug.
f. To findout an easily available, economical, safe and effective remedy for the managementof Hypothyroidism.
TYPE OF STUDY-
Phase-2,Randomized and Rational Study.
PERIOD OF STUDY-
Total duration ofclinical Trial is 90 days with fortnightly follow up for symptoms and monthlyfollow up for Thyroid Function Test.
FOLLOW UP PERIOD-
15 days after treatment.
SELECTION OF CASES
For thepurpose of clinical trial, the patients of Hypothyroidism will be selectedrandomly from OPD and IPD of State Ayurvedic College & Hospital, Lucknowand referred cases of other hospital.
Acareful history, physical examination & necessary investigation will beperformed as per proforma prepared for the present trial.
SAMPLE SIZE-
Minimum of 40 patients of Hypothyroidism from OPD/ IPD of State AyurvedicCollege & Hospital, Lucknow will be selected and treated with the trialdrug. Patients who are using the allopathic drug Levo-thyroxine will be giventhe trial drug after washout period of at least 15 days for the allopathicdrug. There will be 2 groups :-
Group A – Patients will be given capsule of Gomutra bhavit Jalkumbhi Bhasma 500mg BD and KPG Vati 250 mg 2BD empty stomach along with Ujjayi Pranayama at 15min at morning (6-8 am) for 3 months.
Group B – Patients will be given capsule of500 mg BD Gomutra bhavit Jalkumbhi Bhasma and KPG Vati 250 mg 2BD empty stomachfor 3 months.
Minimum 40 Patientswith approximately 10% drop out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who are freshly diagnosed or mild cases of Hypothyroidism with increased TSH level(TSH level between > 4.5-12.5 microIU/ml
- •Patients who are ready to switch over to Ayurvedic medicine and have signed the consent form.
- •4 out of 6 major symptoms and minor symptoms may or may not be signed the consent form.
- •Patients with hypothyroidism who are interested in involving themselves in pranayama practice with drugs treatment.
排除标准
- •1.TSH level above 12.5 microIU/ml.
- •Patients who have under gone any type of thyroid surgery and recent abdominal or spinal surgery.
- •patients whose symptoms are worsely aggravated after leaving the modern drug Levo-thyroxine( in the washout period).
- •Hyperthyroidism, Neoplasia, toxic goiter are excluded..
- •Patients suffering from congenital hypothyroidism.
- •6 Obese female with pregnancy or lactation and children.
结局指标
主要结局
Clinical outcome assessment among the people registered under the study will be done through -
时间窗: 90 days
Increased level of TSH above (4.5microIU/ml),weight gain, oedema, Hoarseness of voice ,constipation,Generalized pain etc
时间窗: 90 days
all signs symptoms are graded 0,1,2,3 on the basis of intensity confirmed by clinical examination before trial.The clinical improvement during and after trial will also be correlated and assess with previous grading.
时间窗: 90 days
次要结局
- Quality of life improvement.(90 days)