Clinical Evaluation Of Amruthadi Kashaya in the management of Sheethapitta,an active controlled clinical study
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Varati Damshta Samsthana Shotha (Inflammation like an insect bite)
研究概览
简要总结
This study is a Open label Comparative Clinical trial toevaluate the efficacy of Amruthadi kashaya as an add on drugto Haridrakhandaand Sarshapathaila.
Subjects are allocated in to study and comparatorgroups respectively.Minimum of 30 patients diagnosed as suffering from Sheethapitta fulfillingthe inclusion criteria irrespective of sex & religion will be selectedfor the comparative study. A separate case sheet pro forma will be prepared& subjects will be examined.
They will be divided in to 2 equalGroups A and B, where Group A will be administered with Amruthadikashaya 50 ml twice daily before food along with Haridrakhanda6gm twice daily before food. In Group B, Haridrakhanda alonewill be administered in the dosage of 6gm twice daily before foodSarshapathaila willbe given for both groups for external application
SUBJECTIVE PARAMETER:
Lakshanasof Sheethapitta
- Varati Damshta Samsthana Shotha(Inflammation like an insect bite)
- Kandu(Severe itching)
- Toda(Excessive pain like pricking)
- Vidaha(Burning Sensation)
- Sa utsanga Saraga Mandala(Red Patches)
- Kshanikotpattivinash(Transient)
Associated symptoms if any:
- Pipasa(excessive thirst)
- Jvara(fever)
- Chhardi(vomiting*)*
- Vibandha(constipation)
- Raktalochanata(reddish discoloration of the eyes)
- Dehasada(tiredness of the body)
OBJECTIVE PARAMETER:
Urticaria activity score=Itch severity score + no of hives
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
- •Subjects with classical lakshana of Sheethapitta.
- •Subjects of either sex & religion within the age group of 18 to 60 years will be included.
- •Subjects who are not having angioedema.
- •Chronic spontaneous urticaria with duration greater than 6 weeks.
- •Episodic urticaria with duration greater than 6 weeks.
- •Subjects who are not on steroid medications.
排除标准
- •Subjects suffering from serious systemic disorders like uncontrolled diabetes mellitus, SLE, Sjogren’s syndrome, autoimmune thyroid diseases, respiratory tract infection
- •Angio edema.
- •Acute urticaria less than 6 weeks.
- •Subjects who are on steroid medications.
结局指标
主要结局
Varati Damshta Samsthana Shotha (Inflammation like an insect bite)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Raktalochanata (reddish discoloration of the eyes)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Kandu (Severe itching)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Toda (Excessive pain like pricking)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Kshanikotpattivinash(Transient)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Vibandha (constipation)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Dehasada (tiredness of the body)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Vidaha (Burning Sensation)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Sa utsanga Saraga Mandala (Red Patches)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Pipasa (excessive thirst)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Jvara (fever)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
Chhardi (vomiting)
时间窗: 1st Assessment on 1st day | 2nd Assessment on 11th day | 3rd Assessment on 21st day
次要结局
- Urticaria Activity Score(1st Assessment on 1st day)
