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临床试验/CTRI/2025/03/082981
CTRI/2025/03/082981尚未招募3 期

Evaluation of classical as well as present era causative factor of Vyanga w.s.r. to Melasma and its management by Manjishthadi Vati and Mukhakantikara Lepa

Institure of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Improvement MASI score and improvement MELASQOl

研究概览

简要总结

It is survey and interventional study

100 diagnosed cases of Vyanga (Melasma) having symptoms like bluish or blackish, painless and thin patches over the face and having age between 18 to 55 years and willing to participate in the study will be recruited for present study after taking their informed consent. Diagnosis of Vyanga will be confirmed by woods lamp examination. Pregnant or lactating mother will be excluded from the study. Routine laboratory investigation like hematological (Hb, TLC, DLC, ESR), liver function test, urine routine and macroscopic will be carried out to rule out any other pathology. On the basis of prepared closed ended questionnaire all the subject will be assessed to evaluate classical as well as present era causative factors for Vyanga (Melasma). Out of surveyed subjects who are willing to participate will be enrolled for clinical trial (32 patients will be enrolled in clinical trial) and randomly divided into two groups( 16 in each group). One group will be given Mukhakantikara Lepa (sufficient quantity)  twice a day and second group will be given Manjishthadi Vati 4 tablet (Each tablet 500mg) twice a day and Mukhakantikara lepa (suffecient quantity) twice a day for two months. Both group subject will be assessed fortnightly for MASI score. Woods lamp examination will be carried out before starting and at the completion of treatment. Trial group subject will be given detailed chart of dos and don’ts. Obtained clinical data will be statistically analyzed by paired and unpaired ‘t’ test. To obtain the magnitude of evaluated causative factors risk ratio of each Nidana will be calculated.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • patients fulfilling the diagnostic criteria of Vyanga and patient willing to participate in the study.

排除标准

  • patient age below 18 years and more than 55 years.Hyperpigmentation other than melasma like Acanthosis nigricans, niveous ota etc.Hyperpigmentation caused due to malignant melanoma, liver disease, congenital mark.Post inflammatory pigmentation or open wound on face.Patient suffering from contagious skin diseases, hereditary skin disorder.Pregnant or lactating women.Patient not willing to participate in the study.

结局指标

主要结局

Improvement MASI score and improvement MELASQOl

时间窗: 8 weeks

(Melasma Quality of Life scale)

时间窗: 8 weeks

次要结局

  • Improvement in Woods lamp examination(8 weeks)

研究者

发起方
Institure of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

shital uddhavrao sarang

Institute of teaching and research in ayurveda , jamnagar ,gujarat

研究点 (1)

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