跳至主要内容
临床试验/CTRI/2020/07/026935
CTRI/2020/07/026935尚未招募4 期

A Clinical Trial of Tulsi Original Green Tea in reducing daily stress

Gujarat Tea Processors and Packers Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月8日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Users may cope better with day to day stress level

研究概览

简要总结

Tulsi(Ossimum Sanctum) is known as Basil leaves are regarded as an ’adaptogen’ oranti-stress agent.  Recent studies have shown that the leaves affordsignificant protection against stress. It has several known health benefits inrespiratory disorders, diabetes mellitus, skin disorders, pain management andacts also as immune modulators.

This clinical study has been planned to assess theability of mixture of Ram tulsi, Shyam tulsi and Vanatulsi Green Tea (TulsiOriginal Green Tea) in reducing Day to day stress in normal individual.  The study also intends tocheck the immunological response of Tulsi Original Green Tea in normalindividual.  Almost 82 per cent of India’spopulation are suffering from stress and those in the sandwich generation (aged35-49) are most affected with around 89 per cent reporting some level ofstress, reveals the Cigna’s 360 well-being survey 2019.

Department of Roganidan and PSAM Hospital will beinvolved for 3 months period and the sample single group size will be 30.

The Material and Methodsshall be Tulsi Original Green Tea will be distributedto people in the vicinity of Kalol who are voluntarily agreeing to participatein the trial and sign consent letter. Individuals participating in the trialwill be assessed with subjective parameters like Pittsburg Sleep Quality Index (PSQI)questionnaire and  Hamilton Depression Rating Scale (HDRS) to assess dayto day stress level on 1st  day, on 15th  dayand on 30th  day. Objective parameters like Routine BPmeasuring on every visit, CBC,ESR, LFT, RFT, IgG, IgE, Anti oxidants will alsobe carried out before and after the study to ascertain the immune responsedeveloped by the Individual.

The proposed outcome isthat Tulsi Original Green Tea is expected to be haveeffective result on reliving day to day stress in normal individuals; it alsoshould bring about immune-modulatory effect.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Healthy Volunteer willing to participate in the study and signed informed consent.

排除标准

  • Patients with any systemic disorders Patients having depression and on medication for any psychiatric disorder Pregnant Women Patients who are under other investigational drugs.

结局指标

主要结局

Users may cope better with day to day stress level

时间窗: 30 days

May have improved sleep

时间窗: 30 days

quality

时间窗: 30 days

Improved anti oxidant serum level

时间窗: 30 days

次要结局

  • Immuno modulatory effect(Improved metabolism)

研究者

发起方
Gujarat Tea Processors and Packers Ltd
申办方类型
Other [Tea Manufacturing Industry Indian]

研究点 (1)

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