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临床试验/CTRI/2016/02/006670
CTRI/2016/02/006670尚未招募1/2 期

A critical study on Shama Prakopau Doshanam Sarvesham Agni Samshritau wsr to Grahanidosha and its management with Nagaradi kashaya

IPGT RA GAU Jamnagar Gujarat1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年2月29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
Subjective: Improvement in classical symptoms of Grahanidosha, Agnibala and Doshavastha.

研究概览

简要总结

This study is open label clinical study to evaluate the effect of Nagaradi Kashaya om Grahanidosha as well as on Agni and Doshavastha.

PLAN OF STUDY

The study will be carried out in two parts.

·         Conceptual study

·         Clinical study

CONCEPTUAL STUDY

Materials and Methods:.

All the available authentic classical texts of Ayurveda, viz. Samhitas, Samgraha, Granthas and their respective commentaries and texts written by eminent of scholars of modern era, latest journals, research papers, periodicals, articles, minutes of seminars, medical literature, available material on internet will be referred keenly to explore the subject. The compiled material will be critically analyzed and evaluated to form the conceptual base of study.

CLINICAL STUDY

Materials and Method:

A detailed and precised proforma will be designed to evaluate the effect of Nagaradi Kashaya on Jatharagni and on the state of Doshas in Grahanidosha. The drug selected for the study will be assessed clinically after taking the proper consent of patient.

SELECTION CRITERIA:

·         The patients having classical signs and symptoms of Grahanidosha viz. Abaddha Mala-Pravritti and Sashleshma Mala-Pravritti, Sushka Varcha, Aam Varcha, Adhmana, Arochaka, Udargaurav, Parshvaruja  etc. will be selected.

·         Patients will be selected from the age group of 16-40 years, irrespective of sex, religion and caste etc.

 EXCLUSION CRITERIA:

·         Age group of less than 16 years and more than 40 years

·         Worm infestation

·         Patients suffering from acute and chronic disease like Ulcerative colitis, Gastric and Peptic ulcer etc.

INVESTIGATIONS:

Following investigations will be carried out to rule out any other pathology:

1.      Complete blood count :

2.      Urine :

Routine and microscopic examinations.

3.      Stool :

Routine and microscopic examinations.

 DRUGS AND GROUPING:

Study design: Interventional

No. of patients: 30

Name of drug : Nagaradi Kashaya (Ch.Chi. 15/98)

Ingredients:

Dravya

Latin name

Part used

Proportion

|Nagara

Zingiber officinale Roxb*.*

Rhizome

1 part

|Musta

Cyperus rotundus Linn*.*

Rhizome

1 part

|Ativisha

Aconitum heterophyllum Wall*.*

Root

1 part

Form : Kashaya (decoction)

Dose : 40 ml twice a day

Sevankala : Niranna Kala

Duration : 2 weeks

CRITERIA FOR ASSESSMENT:

Subjective: Improvement in classical symptoms of Grahanidosha.

Objective: Change in investigations

Data generated during the above study will be presented in systemic manner and will be analyzed by paired t test. Collected, compiled and analyzed data will be presented with proper discussion and an attempt will be made to give concrete conclusion.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
16.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • The patients having classical signs and symptoms of Grahanidosha viz.
  • Abaddha Mala-Pravritti and Sashleshma Mala-Pravritti, Sushka Varcha, Aam Varcha, Adhmana, Arochaka, Udargaurav, Parshvaruja etc.

排除标准

  • Worm infestation Patients suffering from acute and chronic disease like Ulcerative colitis, Gastric and Peptic ulcer etc.

结局指标

主要结局

Subjective: Improvement in classical symptoms of Grahanidosha, Agnibala and Doshavastha.

时间窗: 15 days

Objective: Change in investigations

时间窗: 15 days

次要结局

  • Subjective: Improvement in classical symptoms of Grahanidosha, Agnibala and Doshavastha.(Objective: Change in investigations)

研究者

发起方
IPGT RA GAU Jamnagar Gujarat
申办方类型
Research institution and hospital

研究点 (1)

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