Study of HSSH-062501 Tablets in People with Mild to Moderate Chronic Joint Pain
Scientific Title of Study
A Multicentric, Randomized, Double Blind, Three-Arm, Comparative Clinical Study to Evaluate the Safety and Efficacy of HSSH-062501 in Participants with Mild to Moderate Chronic Joint Pain
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
HWC/MSCD/PP/026/2025 V 1.0, 14th Oct 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Bharath Raj R
Designation
Consultant Orthopaedic
Affiliation
Mithra Multispeciality Hospital
Address
OPD No. 3, Ground floor, Mithra Multispeciality Hospital, Neeladri, No 6, SR Layout, Kyalasanahalli Village Jigani Town, Bommasandra Jigani Link Rd, Electronic City Phase I
Bangalore KARNATAKA 560105 India
Phone
9686343580
Fax
Email
bharathraj.r@gmail.com
Details of Contact Person Scientific Query
Name
Dr Rajesh Kumawat
Designation
Head Of Medical Services and Clinical Development
Affiliation
Himalaya Wellness Company
Address
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore KARNATAKA 562162 India
Phone
8067549904
Fax
Email
rajesh.kumawat@himalayawellness.com
Details of Contact Person Public Query
Name
Dr Soorya Narayan H
Designation
Manager- Clinical Operations
Affiliation
Himalaya Wellness Company
Address
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore KARNATAKA 562162 India
Phone
08067549919
Fax
Email
dr.sooryanarayan.h@himalayawellness.com
Source of Monetary or Material Support
Himalaya Wellness Company
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D)
Makali Tumkur Road, Bangalore
Karnataka, 562162 India.
Primary Sponsor
Name
Himalaya Wellness Company
Address
Himalaya Wellness Company Room No 301, 3rd Floor Medical Services and Clinical Development (R&D) Makali Tumkur Road, Bangalore Karnataka, 562162 India.
OPD No. 2, Ground Floor, B Tower, sundervan complex, Gorwa Refinery Rd, near Gorwa, beside IOCL Petrol pump, Gorwa, 390016 Vadodara GUJARAT
02652760011
amitorthomedicine@yahoo.com
Dr Bharath Raj R
Mithra Multispeciality Hospital
OPD No. 3, Ground floor, Mithra Multispeciality Hospital, Neeladri, No 6, SR Layout, Kyalasanahalli Village Jigani Town, Bommasandra Jigani Link Rd, Electronic City Phase I, 560105 Bangalore KARNATAKA
9686343580
bharathraj.r@gmail.com
Dr Mihir Shah
Nand Multispeciality Hospital
OPD No. 4,Ground Floor, Nand Multispeciality Hospital, Vasna- Bhayli Road, Near by Panchmukhi Hanuman Mandir,
390015.
Vadodara GUJARAT
8780326665
drmihircr@gmail.com
Dr Mohan N S
Pralaksha Hospital
OPD No.4 Ground Floor, Pralaksha Hospital, #40, New Mico Road Hosa Road Market, Hosa Rd, Chennakeshava Nagar, CK Nagar, Sai Sree Layout, Parappana Agrahara, 560100 Bangalore KARNATAKA
9538476000
drmohanns@gmail.com
Dr Tarun Bali
Santosh Hospital
OPD Number 3, Ground floor, 6/1, Promenade Rd, behind Coles Park, Pulikeshi Nagar, Frazer Town, 560005 Bangalore KARNATAKA
9632144300
drtarunbali8@gmail.com
Dr Prasad Soraganvi
Sri Laxmi Hospital
OPD Number 3, Department: Orthopedic, Doddathogur Rd, Electronic City Phase I, Electronic City, Doddathoguru 560100 Bangalore KARNATAKA
(1) Medicine Name: Marketed Shallaki Tab 600mg, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Marketed Shallaki 600mg Tablet. One tablet twice daily orally for 28± 2 days (after food).
2
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Himalaya Shallaki Tab 600mg, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Efficacy study: Himalaya Shallaki 600mg Tablet. One tablet twice daily orally for 28± 2 days (after food).
Safety extension study: Himalaya Shallaki 600mg Tablet. One tablet twice daily orally for 56± 2 days (after food).
3
Comparator Arm
Drug
Other than Classical
(1) Medicine Name: Diclofenac Sodium (75mg) and Similar Placebo , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 75(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Diclofenac (75mg) for first 7 days, then participants will be continued with
Dummy Placebo for next 21 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Adults aged 18 to below 65 years.
2.Diagnosed with one of the following conditions with mild to moderate pain:
Osteoarthritis
Rheumatoid arthritis
Gout
Spondylosis
Other chronic joint pain (e.g., Frozen Shoulder, Tennis Elbow)
3.Pain score between 1 to 6 on the Numerical Rating Scale (NRS).
(Only the most painful site will be considered if multiple sites are involved.)
4.No use of other medicines or supplements for the condition 10 days before screening and during the study.
5.Women of childbearing age and men with such partners must use effective birth control during the study.
6.Men must not donate sperm from the start of the study until 90 days after it ends.
7.Not part of any other clinical study in the last 3 months.
8.Willing to sign informed consent and follow study procedure.
ExclusionCriteria
Details
1.Severe joint pain or recent injury causing immobility
2.Requires injections, surgery, or hospitalization
3.Severe back pain with disc or nerve issues such as sciatica
4.History of joint replacement or mobility-limiting hip or back pain
5.Use of steroids, DMARDs, or joint injections in the past six months
6.Physical disability affecting study assessments
7.History of gastrointestinal bleeding, ulcers, or perforation
8.Active gastrointestinal issues such as GERD or gastritis with GSRS score greater than one
9.Major health conditions such as heart, liver, neurological, or congenital disorders
10.Participants with HbA1c levels equal to or greater than eight percent, indicating uncontrolled diabetes, will be excluded from the study
11.Drug abuse or inability to follow study instructions
12.Pregnant or breastfeeding women
13.Allergy to study product ingredients
14.Any condition affecting study compliance as determined by the investigator
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
All Participants
•Change in 24-hour Average pain intensity (Baseline24hr-EOS24hr) through NRS.
•Participants with 50 percent or more improvement
•Pain at rest and motion
•Tenderness and swelling (not for spondylosis)
•Quality of life improvement
•Rescue medication usage
Rheumatoid Arthritis
•Morning stiffness duration
•Grip strength
•Tender joint count
Osteoarthritis
•Chair stand test
•Stair climb test
•Fast-paced walk test
•Range of motion (also for spondylosis)
Day 0, Day 7, & Day 28
Secondary Outcome
Outcome
TimePoints
Efficacy study:
•Assessment of GI (Gastrointestinal) tolerability
•Incidence of adverse events
Efficacy study:
Day 0, Day 7, Day 28
Extended Safety Study:
•GI (Gastrointestinal) tolerability throughout the study.
•Incidence of adverse events throughout the study.
Extended Safety Study
Day 0, Day 56
Target Sample Size
Total Sample Size="300" Sample Size from India="300" 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/ Phase 3
Date of First Enrollment (India)
18/11/2025
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="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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
Efficacy Study Summary
This clinical study evaluates the safety and efficacy of HSSH 062501 in participants with mild to moderate chronic joint pain. It is a multicentric, randomized, double blind, three-arm interventional study sponsored by Himalaya Wellness Company, Bengaluru. The study includes 300 participants divided into three groups receiving HSSH 062501, Marketed Shallaki, or Diclofenac followed by placebo over 28 days. An open-label safety extension study will follow for 56 days with 40 participants continuing on HSSH 062501.
Title: A Multicentric, Randomized, Double Blind, Three-Arm, Comparative Clinical Study to Evaluate the Safety and Efficacy of HSSH-062501 in Participants with Mild to Moderate Chronic Joint Pain
Objectives: Evaluate safety and efficacy of HSSH 062501
Sponsor: Himalaya Wellness Company, Bengaluru
Type: Interventional
Participants: 300 (100 per arm)
Duration: 28 days
Arms:
·HSSH 062501 (600 mg)
·Marketed Shallaki (600 mg)
·Diclofenac (75 mg for 7 days) followed by placebo