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临床试验/CTRI/2024/07/069950
CTRI/2024/07/069950已完成2/3 期

A CASE CONTROL STUDY OF PALITYA IN THE CONTEXT OF RASAVAHINI DUSYANTI CINTYANAM CATICINTANAT AND RANDOMIZED CONTROLLED TRIAL OF SHANKHPUSHPI SYRUP AS AN ADD ON THERAPY OF KASMARYADI TAILA

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Changes in GSS (greying severity score) in both groups before and after treatment

研究概览

简要总结

PHASE 1 : Case Control study ( Nidanatmaka study )

Case Control Study :

Research Question:

Is there any association between Rasavahini Dusyanti Cintyanam Caticintanat and Palitya on the basis of perseverative thinking questionnaire?

Hypothesis :

Null Hypothesis : There is no association between Rasavahini Dusyanti Cintyanam Caticintanat and Palitya  on the basis of perseverative thinking questionnaire.

Alternate Hypothesis : There is association between Rasavahini Dusyanti Cintyanam Caticintanat and Palitya on the basis of perseverative thinking questionnaire.

AIMS AND OBJECTIVES:

Aim:

To evaluate association between Rasavahini Dusyanti cintyanam caticintanat and Palitya on the basis of perseverative thinking questionnaire.

Objectives :

To find out the association between Rasavahini Dusyanti cintyanam caticintanat and Palitya on the basis of perseverative thinking questionnaire

PHASE 2 : Randomized Comparative Trial

Research Question :

What is the effect of locally applied Kasmaryadi Taila with and without oral administration of Shankhpushpi Syrup in terms of change in Greying Severity Score (GSS) in Palitya before and after treatment that is i.e. day 0, 15, 30?

Hypothesis :

Null hypothesis :

There is no difference between the effect of locally applied Kasmaryadi Tail with and without oral administration of Shankhpushpi Syrup in terms of change in Greying Severity Score (GSS) in Palitya.

Alternate hypothesis :

There is difference between the effect of locally applied Kasmaryadi Taila with and without oral administration of Shankhpushpi Syrup in terms of change in Greying Severity Score (GSS) in Palitya.

AIMS AND OBJECTIVES :

Aim :

To assess the add on effect of orally given Shankhpushpi Syrup with locally applied Kasmaryadi Taila in terms of change in baseline GSS  (greying Severity Score) before and after completion of  therapy.

Objectives :

Primary Objective:

To compare the therapeutic efficacy of locally applied Kasmaryadi Taila as compared to with and without oral administration of Shankhpushpi Syrup in terms of change in Greying Severity Score (GSS) in Palitya.

Secondary Objective:

To assess the changes in clinical signs and symptoms of Palitya before and after treatment that is i.e. day 0,15,30.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patients having grey hairs more than 10 % and upto 75 %.

排除标准

  • Individuals with any known hormonal imbalance problems.
  • Any kind of fungal or other infection of scalp.
  • Pregnant ladies.
  • Other skin disorders like Psoriasis, Eczema,Leucoderma, Seborrhic Dermatitis.
  • Individuals of Pitta Pradhan Prakriti.
  • Individuals giving consent to not use dye/hair colour /bleach during the trial period.

结局指标

主要结局

Changes in GSS (greying severity score) in both groups before and after treatment

时间窗: Changes will be observed in 0, 15 and 30 Days

次要结局

  • Changes in clinical signs & symptoms of Palitya in both groups before & after treatment(sign & symptoms of Palitya like keÅ›a varṇa (color of the hair), ruká¹£a & sphuá¹­ita keÅ›a (Dry & split hair), kapāladāha (Burning sensation in the scalp), svedapravá¹›ti on forehead & scalp(sweatning))

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR ASHA KUMAWAT

National Institute of Ayurveda, Deemed to be University (De-novo)

研究点 (1)

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