CTRI

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CTRI Number

CTRI/2022/07/043651 [Registered on: 01/07/2022] Trial Registered Prospectively

Last Modified On:

25/09/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Screening

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Clinical comparison of Yashtimadhu and Jethimala for their Snigdha property and Balya action.

Scientific Title of Study

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

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Seema J Viramgama
Designation	M.D. Scholar second year
Affiliation	Government Ayurved College, Vadodara
Address	Upgraded post graduate department of Dravyaguna, Government Ayurved College, Dhanvantari marg, Ajwa road, Vadodara,Panigate Vadodara Vadodara GUJARAT 390019 India
Phone	8160070303
Fax
Email	viramgamaseema267@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Dr Bharat Kalsariya
Designation	Principle, I/C Professor and Head
Affiliation	Government Ayurved College, Vadodara
Address	Upgraded post graduate department of Dravyaguna, Government Ayurved College, Dhanvantari marg, Ajwa road, Vadodara,Panigate Vadodara Vadodara GUJARAT 390019 India
Phone	8141854828
Fax
Email	drbharat1977@gmail.com

Details of Contact Person
Public Query

Name	Dr Suman Singh
Designation	Assistant Professor
Affiliation	Government Ayurved College, Vadodara
Address	Upgraded post graduate department of Dravyaguna, Government Ayurved College, Dhanvantari marg, Ajwa road, Vadodara,Panigate Vadodara Vadodara GUJARAT 390019 India
Phone	9510172204
Fax
Email	snghsmn@gmail.com

Source of Monetary or Material Support

Government Ayurved College and Hospital, Ajwa road, Dhanvantari Marg, Panigate, Vadodara

Primary Sponsor

Name	Government Ayurved College and Hospital
Address	Government Ayurved College and Hospital, Ajwa road, Dhanvantari Marg, Panigate, Vadodara
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Seema J Viramgama	Government Ayurveda College and Hospital Vadodara	OPD no.17, Upgraded post graduate Department of Dravyaguna, PG building, 1st floor, Government Ayurveda College, Dhanvantari Marg, Ajwa road, vadodara Vadodara GUJARAT	8160070303 viramgamaseema267@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Volunteers have no complain of any diseased condition and have not taking any medicine

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Yashtimadhu, Reference: Bhavaprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Jethimala, Reference: Bhavaprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1. 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. 2. Participants with physical (weight, BMI) and biochemical parameters (TLC, DC, ESR, RBS) in concern within the normal range.

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Assessment of Snigdha Guna and Balya Karma of Yashtimadhu and Jethimala.	4 weeks

Secondary Outcome

Outcome	TimePoints
Possible establishment of Jethimala as standard substitute for Yashtimadhu.	4 weeks

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "103"
Final Enrollment numbers achieved (India)="103"

Phase of Trial

N/A

Date of First Enrollment (India)

01/07/2022

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="2"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

Clinical study has obtained a comparative clinical assessment of snigdha guna and balya karma of yashtimadhu (glycyrrhiza glabra linn.) and jethimala (taveniera cuneifolia (roth) ali.) Clinical study has obtained Institutional Ethics Committee clearance (GAV/VAD/IEC/72/2021 date- 15/09/2021) and registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2022/07/043651 [Registered on: 01/07/2022]. Study type was open labelled parallel armed randomized clinical 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 of Government Ayurvedic College, Vadodara were carried out prior to initiation of clinical study. Among them Volunteers having Vata predominance Prakruti and matched with inclusion criteria were enrolled for study. Total 104 volunteers were enrolled in the study of which 51 completed the study in Group A (3gm Yashtimadhu Churna- 2time per day before meal) and 52 completed the study in Group B. i.e. (3gm Jethimala Churna- 2time per day before meal). In Yashtimadhu Churna highly significantly (p<0.0001) effect on Rukshata i.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 Dhatuvardhana (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 statically highly significant result on 17 parameters out of 36 parameters. In Jethimala Churna highly significantly (p<0.0001) effect on Rukshata i.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 Dhatuvardhana (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 statically highly significant result on 17 parameters out of 36 parameters. The overall effect of the therapy on 103 volunteers of Snigdha Guna in two groups has been evaluated based on 31 parameters out of 36 parameters (here 5 parameters i.e. Panchendriya Shakti was excluded as all three group exhibits 0% of result on it.) and In Yashtimadhu Churna highly significant (p<0.0001) effect on parameters 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%). It has produced statically highly significant result on 17 parameters out of 18 parameters. In Jethimala highly significantly (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%). It has produced statically highly significant result on 17parameters out of 18 parameters. Balya Karma in 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 effect no change in 90.19% and mild improvement in 7.846% and moderate improvement in 1.96%.While overall effect of therapy is 19.86%. Yashtimadhu Churna in Balya Karma effect no change found in 92.6% and mild improvement in 3.92% and moderate improvement in 1.96%.While overall effect of therapy is 35.78. Jethimala Churna in Singdha Guna effect no change in 92.30% and mild improvement in 5.77% and moderate improvement in 1.92%.While overall effect of therapy is 13.91%. Jethimala Churna in Balya Karma effect no change found in 92% and mild improvement in 3.85% and moderate improvement in 3.85%. While overall effect of therapy is 25.42%. no change result was not found in any Groups.