"Comparative evaluation of the efficacy of kaishore guggulu,giloyghan vati and bodhivriksha kashaya with madhu in primary hyperuricemia (Vatarakta)"
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.Itching
研究概览
简要总结
Group-A - 2-2 tablet each of Kaishore guggulu and Giloy ghan vati will be given to the
patients.
Group-B - 40 ml of Bodhivriksha kashaya with 2 tsf madhu will be
given to the patients.
Kaishor guggulu and Giloy ghan vati will be advice to take 1 st dose in morning at 9:00 a.m.
and 2 nd dose at 9:00 p.m. after having breakfast.
Bodhivriksha kashaya with madhu will be advice to take 1 st dose in the morning at 6:00 a.m.
and 2 nd dose at 6:00 p.m. on empty stomach.
Route of administration- oral
Follow up : The follow up will be done after 15 days and 1 month during the trial of
1 month to observe the effects of treatment or any adverse effects on the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between the age group of 18 -70 years will be selected.
- •2.Patients having serum uric acid > 7mg/dl in male and> 6mg/dl in female or more than upper normal limit.
- •3.Patients not having any associated chronic ailment.
- •4.Patient with symptoms of Vatarakta and primary hyperuricaemia will be selected for the study.
- •5.Patients irrespective of sex, religion, occupation will be selected for the study.
排除标准
- •1.Patients aged < 18 years or> 70 years will be excluded.
- •2.Pregnant or lactating mother will be excluded.
- •3.Patients with renal disorder, liver disease, osteoarthritis, rheumatoid arthritis, Diabetes mellitus, obesity, hypothyroidism or hyperthyroidism, chronic haemolytic anaemia, auto immune disorders, and any other co-morbid condition will be excluded.
结局指标
主要结局
1.Itching
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
3.Burning sensation
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
4.Malaise
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
1.Sign of primary hyperuricemia
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
Tenderness
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
Subjective Parameters-
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
2.Pain
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
2.Serum uric acid before the treatment
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
Objective Parameters-
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
Local colour changes in the skin
时间窗: Before intervention with Kaishore guggulu, giloyghan vati and Bodhivriksha Kashaya
次要结局
- Subjective Parameters-(1.Itching)