An open label single arm clinical study on the combined effectiveness of Chitrakadi Vati and Avipathi Churnam in the management of Hypothyroidism
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Deafness
研究概览
简要总结
Current clinical study is single arm clinical trial toevaluate the combined effectiveness of Chitrakadi Vati and Avipathi Churnam-twoAyurveda formulations in the management of hypothyroidism.In the present study, an open label single armclinical trial at IPD basis will be done with pre and post-test design for theincluded 30 patients.Here Chitrakadi Vati 250 mg twice daily in the morning andnight will be administered before food with ushnodaka as anupana for the first8 days.On the 9th day Koshta Shuddhi (administration of laxativemedicine for internal purification) as a part of srotosodhana will be done with Avipathi Churnam in a dose of 10gms with Honey inearly morning in empty stomach.Samsarjana karma (wholesome diet) will beobserverd for the next day.The patient will be discharged with Chitrakadi vatifor the next 30 days.After 30 days,the second course of Koshta Shuddhi(administration of laxative medicine for internal purification) will bedone with Avipathi churnam in the same dose i.e on the 40th day.Onthe next day samsarjana karma (wholesome diet) will be observed.The patientwill be discharged with Chitrakadi vati to be taken in the same dose as beforefor 30 days.After 30 days i.e on the 70th day last course of KoshtaShuddhi will be done with Avipathi Churnam in the same dose as before.On thenext day samsarjana karma will be observed and the patient will be dischargedwith Chitrakadi vati for the next 20 days i.e till the 90thday.Hence the entire treatment will be completed in 90 days.
Thepatient will be assessed on the 1st day and 90th day withinvestigations like Thyroid profile and BMI. The signs and symptoms will beassessed using Billewicz scoring system on the 1st day, 10thday, 41st day, 71st day and on the 90th day.Assessment would be done based on subjective and objective parameters and wouldalso be monitored for Adverse Drug Reactions or Adverse Drug Effects or otherconcurrent illness
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis will be made on the basis of TSH value more than 15-20 mU/l which may or may not be associated with decrease in T3 and T4 concentration and also with the signs and symptoms of Hypothyroidism one or multiplicity of these viz 1.tiredness, 2.dryness of skin, 3.feeling cold 4.hair loss, 5.constipation, 6.Weight gain with poor appetite 7.Hoarseness of voice, 8.muscle ache or stiffness, 9.menstrual disturbances, 10.Bradycardia 11.periorbital puffiness.
- •Inclusion criteria include 1.Patients of age between 18 to 60 years of either gender 2.Patients already diagnosed as hypothyroidism with or without medication, 3.Patients with Primary hypothyroidism, 4.Patients with subclinical hypothyroidism, 5.Patients who are ready to sign the informed consent form.
排除标准
- •Exclusion criteria are as follows 1.Patients who have undergone any type of thyroid surgery, 2.Patients suffering from systemic diseases like Ischemic Heart Disease, Diabetes mellitus, carcinomas, 3.Patients suffering from congenital hypothyroidism, 4.Pregnancy and lactation, 5.Rapid progressive case of myxedema, 6.Hypothyroidism due to drug therapy (e.g. Amiodarone, Lithium, Interferon) 7.Hypothyroidism due to infiltrative diseases like Sarcoidosis,Scleroderma and Haemochromatosis.
结局指标
主要结局
Deafness
时间窗: 90 DAYS
The parameters in BILLEWICZ SCORE are the following signs and symptoms:
时间窗: 90 DAYS
Assessment of subjective parameters will be done on 1st day,10th day, 41st day, 71st day and 90th day with the help of a suitable clinical scoring of hypothyroidism – BILLEWICZ SCORE
时间窗: 90 DAYS
Symptoms are Diminished sweating,Dry skin,Cold intolerance,Weight increase,
时间窗: 90 DAYS
Constipation, Hoarseness of voice and
时间窗: 90 DAYS
Signs are Slow movements, Coarse skin,
时间窗: 90 DAYS
Cold skin, Periorbital puffiness, Pulse rate and Ankle jerk
时间窗: 90 DAYS
次要结局
- Serum T3, T4, TSH(90 days)