FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095727 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 30/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check the effectiveness of study drug in rheumatoid arthritis participants 
Scientific Title of Study   A Randomized, Controlled, Double-Blind, Comparative Study to Evaluate the Effect of Sallapam Plus with or without low-dose serratiopeptidase in Patients with Rheumatoid Arthritis 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
ETM/001/2025 ,Version 1.0, dated 20/Aug/2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lokesh Holagundi  
Designation  Orthopaedic Surgeon 
Affiliation  Health India Hospital 
Address  Health India Hospital, Orthopedic department, Room NO-02,Ground floor. 7, 6th Cross, Tavarekere Main Road, Chikka Adugodi, Bangalore-560029

Bangalore
KARNATAKA
560029
India 
Phone  7760628844   
Fax    
Email  loksdoc@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Mr Hasan Ali Ahmed  
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd.  
Address  Xplora Clinical Research Services Pvt Ltd. Krishna Arcade 3rd Floor, #23,5th Main, 12th Cross, Wilson Garden, Hombegowda Nagar, Bangalore-560027

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Details of Contact Person
Public Query  
Name  Mr Manik Chaudhuri  
Designation  Project Manager 
Affiliation  Xplora Clinical Research Services Pvt. Ltd.  
Address  Xplora Clinical Research Services Pvt Ltd. Krishna Arcade 3rd Floor, #23,5th Main, 12th Cross, Wilson Garden, Hombegowda Nagar, Bangalore-560027

Bangalore
KARNATAKA
560027
India 
Phone  9738651205  
Fax    
Email  manik@xplorahealth.com  
 
Source of Monetary or Material Support  
Eutherva Medicament Pvt. Ltd Orchard Mall Rd, Royal Palms, Aarey Milk Colony, Goregaon, Mumbai, Maharashtra 400065, India 
 
Primary Sponsor  
Name  Eutherva Medicament Pvt. Ltd 
Address  Orchard Mall Rd, Royal Palms, Aarey Milk Colony, Goregaon, Mumbai, Maharashtra 400065, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nill   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lokesh Holagundi  Health India Hospital  Orthopedic department, Room NO-02,Ground floor. 7, 6th Cross, Tavarekere Main Road, Chikka Adugodi, Bangalore-560029
Bangalore
KARNATAKA 		 7760628844

loksdoc@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pranav Diabetes Center Ethics Committee  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. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Sallapam Plus, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Sallapam plus with low dose of serratiopeptdase, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Male and female participants aged over 20-65 years
2) Participants have been diagnosed with rheumatoid arthritis by
a general practitioner and or orthopedic physician or surgeon
according to the 2010 American College of Rheumatology
168 (ACR).
3) Able to evaluate disease activity by themselves.
4) Participants who have no plans to start new treatments during
the study period
5) Patients who require anti-inflammatory treatment, do not
use anti-inflammatory analgesic medications on a regular
basis, or are unsatisfied with their treatments and want to
alter them.
6) Patients ready to give written informed consent and willing
to comply the study protocol.  
 
ExclusionCriteria 
Details  1) Participants using other complementary and alternative
medicine or any addiction to psychotropic agents and
opioids.
2) Participants with uncontrolled medical conditions such as
diabetes, uncontrolled hypertension, cardiovascular disease,
gallbladder disease, renal disease, endocrine disease, or
malignancies, neurological diseases, or psychiatric
conditions.
3) Patients with concurrent rheumatoid diseases and gout. Use
of biologic agent therapy in the last 6 months.
4) Participation in any other clinical trial within 30 days of
screening.
5) Any history of allergy to any of the drugs investigational
products.
6) Pregnant and lactating women and women of childbearing
age who do not follow adequate contraceptive measures. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Change in pain levels assessed by the Visual Analogue
Scale (VAS) score from baseline to the end of the treatment.
2) Improvement in sleep quality as measured by the Athens
Insomnia Scale (AIS) scores, from baseline to the end of the
study. 		 Visit-01, Visit-02, Telephonic Visit, Visit-04 
 
Secondary Outcome  
Outcome  TimePoints 
1) Change in serum cortisol levels from baseline to the end of
treatment.
2) Change in serum levels of C - reactive protein (CRP) from
baseline to the end of treatment.
3) Change in Erythrocyte Sedimentation Rate (ESR) from
baseline to the end of treatment.
4) Change in Health-Related Quality of Life (HRQOL) Using
the SF-36 Score.
5) Changes in overall health status and treatment effectiveness
assessed by Subject Global Assessment (SGA) and
Physician Global Assessment (PGA) scores from baseline
to the end of treatment.
6) Change in vital signs, and laboratory safety parameters
including CBC, liver function tests (SGPT and SGOT) and
kidney function tests (Sr. creatinine).
7) Incidence of adverse events related to the study
interventions recorded throughout the study period.  		 Visit-01, Visit-02, Telephonic Visit, Visit-04 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 4 
Date of First Enrollment (India)   14/10/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disorder characterized by persistent synovial inflammation, joint destruction, pain, fatigue, and significant functional impairment, affecting approximately 0.5-1% of the global population and imposing a substantial burden on quality of life and healthcare systems.this study aims to evaluate the clinical efficacy and safety of Sallapam Plus alone compared to Sallapam Plus combined with low-dose serratiopeptidase in patients with active RA over 90 days (3 months).Sallapam Plus is a proprietary, multi-ingredient herbal formulation traditionally marketed for musculoskeletal conditions such as arthritis, myalgia, and joint stiffness. Its composition typically includes Jatamansi (Nardostachys jatamansi) and Shallaki (Boswellia serrata), both of which have documented anti-inflammatory, antioxidant, and neuroprotective properties.The investigational use of Sallapam Plus, with or without low-dose serratiopeptidase, is expected to offer several potential benefits to patients with RA, particularly in reducing joint pain, improving sleep quality, enhancing cognitive function, and alleviating systemic inflammation through its herbal and enzymatic mechanisms.
The treatment continues for a period of three months (90 days). The total duration of the study is 12 months.
In this study 24 participants—12 in each treatment arm—has been chosen to allow for a comparative evaluation of clinical trends, feasibility of study procedures, and potential therapeutic signals.  
The schedule of assessment for this study spans a duration of 90 days and comprises two site visits: the screening visit (V1), baseline visit (V2) and end-of-study visit (V4). Additionally, subjects will undergo periodic telephone follow-ups throughout the treatment period to monitor their progress and product compliance.
Participants will complete VAS, AIS, FCT, DAS28 and SF-36 Quality of Life assessments, along with SGA and PGA scores in screening and end of visit. Blood samples will be drawn for Screening and End of visit: serum TAC, CRP, ESR, cortisol and fibrinogen as well as safety parameters including CBC, SGPT, SGOT, and Sr. creatinine. Adverse events reported throughout the study will be reviewed, and participants will return any unused medication.
 
Close