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临床试验/CTRI/2022/07/043651
CTRI/2022/07/043651已完成不适用

A Comparative Clinical Assessment of Snigdha Guna and Balya Karma of Yashtimadhu (Glycyrrhiza glabra Linn.) and Jethimala (Taverniera cuneifolia (Roth) Ali

Government Ayurved College and Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Assessment of Snigdha Guna and Balya Karma of Yashtimadhu and Jethimala.

研究概览

简要总结

Clinical study has obtained a comparative clinicalassessment of snigdha guna and balyakarma of yashtimadhu(glycyrrhiza glabra linn.) and jethimala(taveniera cuneifolia (roth) ali.) Clinical study has obtained Institutional Ethics Committeeclearance (GAV/VAD/IEC/72/2021 date- 15/09/2021) and registered at ClinicalTrial Registry of India, ICMR, New Delhi, vide CTRI/2022/07/043651 [Registeredon: 01/07/2022]. Study type was open labelled parallel armed randomizedclinical study. Selected patients were randomly divided into two groups viz,Group A (Yashtimadhu churna)and Group B (Jethimala Churna). Prakruti analysis survey of 175 student ofGovernment Ayurvedic College, Vadodara were carried out prior to initiation ofclinical study. Among them Volunteers having Vata predominance Prakruti and matched with inclusioncriteria were enrolled for study. Total 104 volunteers were enrolled in thestudy of which 51 completed the study in Group A (3gm Yashtimadhu Churna- 2timeper day before meal) and 52 completed the study in Group B. i.e. (3gm Jethimala Churna- 2time per day beforemeal).In Yashtimadhu Churna  highly significantly (p<0.0001) effect on Rukshatai.e Lalata (29.03%), Kesha (16.27%), Chakshu (21.24%), Ostha(27.19%), Nasabhyantara (22.76%), Karnabhyantara (27.52%), Nakha(15.69%) and Twaka (36.37%), Padadari (26.27%) as well as on Dhatu**vardhana (24.02%),Mutraa Pravruti-colour (17.32%), Mala Pravruti-consistency(11.44%), Agni (22.88%), Varna(32.68%), Bala (17.64%), Trishna(31.70%),Nidra(40.20%) and on Skin moisture(9.21%). It has produced staticallyhighly significant result on 17 parameters out of 36 parameters. In Jethimala Churna  highly significantly (p<0.0001) effect on Rukshatai.e Lalata (18.36%), Kesha (9.61%), Chakshu (12.79%), Ostha(23.21%), Nasabhyantara (16.31%), Karnabhyantara (18.65%), Nakha(15.83%) and Twaka (21.10%), Padadari (16.35%) as well as on Dhatu**vardhana (24.5%), Mutraa Pravruti-colour (12.33%),Mala Pravruti-consistency (12.66%), Agni (14.33%), Varna(18.5%),Bala (13.66%), Trishna(21.83%), Nidra(36%)and on Skin moisture(2.30%). It has produced staticallyhighly significant result on 17 parameters out of 36 parameters. The overall effect of the therapy on103 volunteers of Snigdha Guna in two groups has been evaluated based on31 parameters out of 36 parameters (here 5 parameters i.e. Panchendriya Shaktiwas excluded as all three group exhibits 0% of result on it.) and InYashtimadhu Churna  highly significant (p<0.0001) effect onparameters like Weight(1.67%), BMI (1.70%),Gatralaghava (19.61%), Kshudha (25.49%), Sthirata (19.61%), Kshama (2.94%), Dhriti (17.65%), Jaranashakti(47.06%), Daily activities (52.94%), Balavriddhi(55.88%),Ruchi(34.31%),Concentration(40.52%), Memory (37.58%), Hb% (3.95%), IQ (253.9%). Ithas produced statically highly significant result on 17 parameters out of 18parameters. In Jethimala highlysignificantly (p<0.0001) effect on parameters liked Weight (1.30%), BMI (1.34%),Gatralaghava (13.46%), Kshudha (19.87%), Prasada (11.53%), Sthirata(7.19%), Kshama(14.42%), Dhriti(2.88%), Jaranashakti(10.58%),Daily activites (39.42%), Balavriddhi (45.19%),Ruchi (19.23%),Concentration (27.56%), Memory (25.67%),Hb% (0.50%), IQ (197.4%). Ithas produced statically highly significant result on 17parameters out of 18parameters. Balya Karmain two groups has been evaluated based on 17 parameters out 18 parameters.(Height was excluded as all two group exhibits 0% result on it.). Yashtimadhu Churna in Singdha Guna effectno change in 90.19% and mild improvement in 7.846% and moderate improvement in1.96%.While overall effect of therapy is 19.86%. Yashtimadhu Churnain Balya Karma effect no change found in 92.6% and mild improvementin 3.92% and moderate improvement in 1.96%.While overall effect of therapy is35.78.Jethimala Churna in Singdha Guna effect no change in92.30% and mild improvement in 5.77% and moderate improvement in 1.92%.Whileoverall effect of therapy is 13.91%. Jethimala Churna in Balya Karma effectno change found in 92% and mild improvement in 3.85% and moderate improvementin 3.85%. While overall effect of therapy is 25.42%. no change result was notfound in any Groups.

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Healthy individual (those without any physical and mental ailments and the parameters below mentioned to be in normal range) of either gender in age group of 18-50 years.
  • Participants with physical (weight, BMI) and biochemical parameters (TLC, DC, ESR, RBS) in concern within the normal range.

排除标准

  • 1.Having age less than 18 years and more than 50 years.
  • Uncontrolled clinical conditions like Uncontrolled HTN, cancer, HIV, HBsAg, CKD, Liver cirrhosis, Cardiac failure, Stroke etc.

结局指标

主要结局

Assessment of Snigdha Guna and Balya Karma of Yashtimadhu and Jethimala.

时间窗: 4 weeks

次要结局

  • Possible establishment of Jethimala as standard substitute for Yashtimadhu.(4 weeks)

研究者

发起方
Government Ayurved College and Hospital
申办方类型
Research institution and hospital

研究点 (1)

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