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CTRI Number  CTRI/2025/02/080621 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Herbal ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study Of Glycyrrhiza glabra extract in rheumatoid arthritis. 
Scientific Title of Study   A randomized, single-blind, placebo-controlled clinical trial to evaluate the efficacy of Glycyrrhiza glabra extract in participants with rheumatoid arthritis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/043 Version: 2.00; dated 28 January 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ameya Pathak 
Designation  Principal Investigator 
Affiliation  Sangvi Multispecialty Hospital Pvt. Ltd. 
Address  Sr No 71/1/2/189 City Survey No 2387 Krushna Chowk Krushna Nagar New Sangvi
-
Pune
MAHARASHTRA
411027
India 
Phone  9873017652  
Fax  -  
Email  dramey.sangvihospital@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sriram Padmanabhan 
Designation  Chief Scientific Officer 
Affiliation  SAVA HEALTHCARE LIMITED 
Address  SAVA HEALTHCARE LIMITED Sava House Off New Airport Road Viman Nagar

Pune
MAHARASHTRA
411014
India 
Phone  7507003688  
Fax  -  
Email  sriram.p@savaglobal.com  
 
Details of Contact Person
Public Query  
Name  Dr Sriram Padmanabhan 
Designation  Chief Scientific Officer 
Affiliation  SAVA HEALTHCARE LIMITED 
Address  SAVA HEALTHCARE LIMITED Sava House Off New Airport Road Viman Nagar

Pune
MAHARASHTRA
411014
India 
Phone  7507003688  
Fax  -  
Email  sriram.p@savaglobal.com  
 
Source of Monetary or Material Support  
SAVA HEALTHCARE LIMITED Sava House Off New Airport Road Viman Nagar Pune India 411014 
 
Primary Sponsor  
Name  SAVA HEALTHCARE LIMITED 
Address  Sava House Off New Airport Road Viman Nagar Pune India 411014 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr D G Dipankar  Dr.D.Y.Patil college Of Ayurved and Research Centre  Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad
Pune
MAHARASHTRA 		 9156473172
-
drdgdipankar@gmail.com 
Dr Ameya Pathak  Sangvi Multispeciality Hospital Pvt. Ltd  Sr. No. 71/1/2/189 City Survey No 2387 Krushna Chowk Krushna Nagar New Sangvi.
Pune
MAHARASHTRA 		 9873017652
-
dramey.sangvihospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Dr. D. Y. Patil College of Ayurved and Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Glycyrrhiza glabra extract along with standard of care (SOC)  Two capsules twice daily (four capsules per day) 30 minutes after breakfast and dinner with 240 ml of water along with SOC as determined by the investigator for 90 days 
Comparator Agent  Placebo along with SOC  two capsules twice daily (four capsules per day) 30 minutes after breakfast and dinner with 240 ml of water along with SOC as determined by the investigator for 90 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Male and female participants 30 to 60 years of age (both inclusive) who present RA (rheumatoid arthritis), diagnosed according to ACR or EULAR 2010 criteria with a total score of greater than equal to 6 2. Mild disease activity, indicated by a DAS 28 score greater than equal to 2.6 to smaller than 3.2 3. Participant exhibiting clinically apparent symptoms such as joint swelling and tenderness greater than equal 12 weeks.4. Participants should have been diagnosed with rheumatoid arthritis within the past 3 months and their dose of disease-modifying antirheumatic drug(s) must have been stable for at least 8 weeks prior to trial participation.5. Participants having VAS score in between 4 to 6 . 6. Willing to give informed consent for the study 
 
ExclusionCriteria 
Details  1. Participants with other systemic complications of RA like rheumatic heart disease (RHD), rheumatic fever, pleural pericardial disease
2. Participants diagnosed with or history of dengue and chikungunya, other arthritis like, gouty arthritis, tuberculous arthritis etc. However, participants with radiologically confirmed osteoarthritis (OA) may be excluded at the investigators discretion if the severity of osteoarthritis is judged to interfere with the study assessment
3. Participants undergoing physiotherapy or oil massages for pain relief.
4. Allergy, sensitivity, or contraindication to interventional product
5. Participants receiving anticoagulant and or antiplatelet agents (high dose aspirin (greater than 100 mg per day)
6. Participants who are unable to walk without support and or confined to a wheelchair
7. Participants with a history of or currently on a biologic (tumor necrosis factor blocking agents) or targeted synthetic DMARDs treatment or other biologic treatment
8. Use of corticosteroids within 2 weeks prior to study entry or planned use within 12 weeks of randomization
9. Chronic antibiotic therapy, if the investigator considers this may affect the safety of the participant or the assessment of the study results
10. History of psychiatric disorder that may impair the ability of the participant to provide written informed consent
11. A history presenting RA encompassing more than a year
12. Participation in any RA-related or any other trials involving investigational products within 30 days before the screening visit
13. Participants treated with any investigational drug in the preceding 4 weeks
14. Female participants with a positive pregnancy test or lactating
15. History of drug, alcohol abuse or dependence
16. History of septic arthritis within a native joint within the last 12 months
17. Organ transplantation history
18. Participants unable to comply with the treatment regimen
19. Participant currently using any enzyme, nutraceutical, ayurvedic, herbal supplement for RA
20. Participants with any other condition that, in the opinion of the investigator, does not justify the inclusion of the participant in the study.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Achieving the American College of Rheumatology (ACR20) Responder Index It is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA)
2. Changes in Visual Analogue Scale (VAS) pain score.
3. Change in the Disease Activity Score Based on a 28-joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
4. Changes in the levels of urinary CTX-II, serum hsCRP, s-CoLL2-1NO2,s-COMP. 		 1.At baseline and day 90.
2.At screening, baseline, day 7, day 30, day 60 and day 90.
3. At screening and day 90.
4. At screening and day 90.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Median of individual participants mean duration of morning joint stiffness based on a 7 day recall at baseline, and recorded in participant diaries .
2. Mean severity of morning joint stiffness using Numeric Rating Scale (NRS) based on a 7 day recall at baseline, and recorded in participant diaries .
3. Change from baseline in the Indian version of the Health Assessment Questionnaire disability index (HAQ DI) score .
4. Mean worst tiredness using numeric rating scale based on a 7 day recall at baseline, and recorded in participant diaries
5. Assessment of requirement of anti inflammatory and analgesic (eterocoxib) as a rescue medication .
 		 1.At day 7, day 30, day 60 and day 90.
2. Day 7, day 30, day 60 and day 90.
3.Baseline and day 90.
4.At day 7, day 30, day 60 and day 90.
5.At day 7, day 30, day 60 and day 90
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   RA is a chronic autoimmune disorder characterized by inflammation in the joints, leading to pain, swelling, stiffness, and eventual joint damage. Although current treatments such as disease-modifying Antirheumatic drugs (DMARDs) and biologics can be effective, they often come with significant side effects, including immunosuppression, gastrointestinal issues, and increased risk of infections. As a result, there is an increasing interest in complementary and alternative therapies, including herbal medicines, to manage RA. One such herb, Glycyrrhiza glabra (licorice), contains bioactive compounds such as glabridin, which have demonstrated anti-inflammatory, antioxidant, and immune-modulating properties. This clinical trial aims to investigate the therapeutic potential of glabridin as an adjunctive treatment for RA.
Despite advances in pharmacologic treatments, many RA participants continue to experience inadequate symptom control, side effects from long-term drug use, or a combination of both. Conventional RA therapies can also fail to address the underlying inflammation and immune dysregulation in some individuals. Therefore, there is a need for alternative treatments with a better safety profile that can complement existing therapies. Herbal medicines like Glycyrrhiza glabra (licorice), which have a long history of use in traditional medicine, may offer an innovative approach to improving disease management with fewer side effects. However, clinical evidence supporting its efficacy in RA remains limited, necessitating further investigation.
 
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