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临床试验/CTRI/2023/07/055801
CTRI/2023/07/055801尚未招募1/2 期

Clinical Evaluation Of Amruthadi Kashaya in the management of Sheethapitta,an active controlled clinical study

Dr Chithra Ramachandran1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月8日最近更新:

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)

研究者

发起方
Dr Chithra Ramachandran
申办方类型
Private medical college

研究点 (1)

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