| CTRI Number |
CTRI/2024/07/070087 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Commiphora myrrha capsule 100 mg for the treatment of patient with Arthritis |
|
Scientific Title of Study
|
An open label, randomized, two arms trial to evaluate the safety and efficacy of extract of Commiphora myrrha (Myrlimax capsule) in comparison to etoricoxib in patients with arthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARC/AH/CM/2024 version 01 04-Feb-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pakanati krishna Sravanth |
| Designation |
principal investigator |
| Affiliation |
Aditya multispeciality hospital |
| Address |
Aditya multispeciality hospital Room No:01,First Floor,Depertent of Orthopedics, Gunturvari thota kothapeta Guntur Andhra Pradesh
Guntur
ANDHRA PRADESH
522001
India |
| Phone |
8500454689 |
| Fax |
08632220395 |
| Email |
researchaditya26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mitta Raghavendra |
| Designation |
Research Supervisor |
| Affiliation |
Vignans Foundation for Science Technology and Research |
| Address |
Associate Professor
Department of Pharmaceutical Sciences
Vignans Foundation for Science Technology and Research Vadlamudi village Guntur
Guntur
ANDHRA PRADESH
522213
India |
| Phone |
9948773693 |
| Fax |
|
| Email |
mittargv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komaragiri krishna |
| Designation |
Research Scholar |
| Affiliation |
Vignans Foundation for Science Technology and Research |
| Address |
Department of Pharmaceutical Sciences
Vignans Foundation for Science Technology and Research Vadlamudi village Guntur
Guntur
ANDHRA PRADESH
522213
India |
| Phone |
8247213001 |
| Fax |
|
| Email |
kkrishna9117@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aditya Research Center, 4th line, Guntuurvari thota, Kothapeta, Guntur, A.p -522001, India |
|
|
Primary Sponsor
|
| Name |
VIGNANS FOUNDATION OF SCIENCE, TECHNOLOGY AND RESEARCH |
| Address |
VADLAMUDI GUNTUR ANDHRA PRADESH 522213 INDIA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aditya Research Center |
13-3-52, 4th line, Gunturuvari thota, Kothapeta, Guntur, A-P 522201, india |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr pakanati krishna sravanth |
ADITYA MULTI SPECIALITY SOPITAL |
Aditya multispeciality hospital Room No:01,First Floor,Depertent of Orthopedics, Gunturvari thota kothapeta Guntur Andhra Pradesh
Guntur
ANDHRA PRADESH |
8500454689
08632220395
researchaditya26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Aditya Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etoricoxib 90mg |
Drug, Etoricoxib 90mg, One capsules in the morning after breakfast for 30 days through oral route |
| Intervention |
myrlimax capsule 100mg |
Nutraceuticals, two capsules daily in morning and evening after breakfast for 30 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of arthritis rheumatoid arthritis
2. osteoarthritis gout arthritis based on history clinical presentation and radiological findings
3. Minimum VAS 4 on walking in one or both hands or knee during 24 hours preceding requirement
4. Patient ambulant and requiring treatment for arthritis
5. Post operative patients are also eligible
6. Willing to come for regular follow up visits
7. Able to give written informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Known history of hypersensitivity to herbal extracts or dietary supplements.
2. Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found to positive for urine pregnancy test.
3. Patient incapacitated or bound to wheelchair or bed and unable to carryout self- care activities.
4. Treatment with intra- articular injection of corticosteroids into knee within 3 months preceding study.
5. Pre- existing or recent onset of demyelinating disorders or type I diabetes.
6. Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine.
7. Evidence of serval renal, hepatic or hemopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations.
8. Patient with congestive heart failure.
9. Patient with hypertension
10. Clinically significant untreated hyper-lipidaemia in context of cardiovascular risk
11. History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing.
12. Ayurvedic formulation or any form of CAM (complimentary alternative medicine) therapy in the preceding 2 months.
13. Non- co- operative attitude of patients
14. Any condition that in the opinion of the investigator does not justify the patient’s inclusion for the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Commiphora myrrha (Myrlimax capsule) with etoricoxib in managing the patients with painful arthritis.
change from baseline to end of the study in scores in simple reaction time
|
Mean change in WOMAC – total score (Day 0, day 15 and Day 30)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in WOMAC – pain subscale.
2. Mean change in WOMAC – stiffness subscale.
3. Mean change in WOMAC – function subscale.
4. Mean change in VAS pain scale.
5. Mean change in distance walked in 6 minutes.
6. Mean change in European Q5D quality of life.
7. Mean change in biomarker (Hs-CRP, ESR, collagen specific binding antibody count, TNF- alpha, IL1-beta and IL-6).
8. Safety assessment through laboratory test.
9. Mean change in physician’s global assessment.
10. Mean change in the radiological parameters.
11. Safety assessment through change in vital sign, physical examination, adverse events.
12. Mean change in WOMAC – total score fore residual effect.
13. Mean scale change in VAS pain scale for residual effect
|
1. Day 0, day 15 and day 30.
2. Day 0, day 15, day 30.
3. day 0, day 15, day 30.
4. screening day, day 15, day 30.
5. day 0, day 15, day 30.
6. day 0, day 30.
7. day 0 and day 30.
8. day 0, day 30.
9. screening day, day 15 day 30.
10. screening, day 15 and day 30.
11. day 0, day 15 day 30.
12. day 30 and day 45.
13. day 30 and day 45
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Now a days, most people are suffering from arthritis. In arthritis conditions, severe pain will be present. Etoricoxib is one of the drugs used to relieve pain in arthritis patients. Etoricoxib is more effective, but it will cause some ADRs in patients, such as cardiovascular problems and renal and gastrointestinal problems. Myrlimax capsules are also used in the treatment of arthritis patients. It is more effective in reducing pain, and it also has fewer side effects. It has more properties, like being gastroprotective, anti-inflammatory, and analgesic. So in the study, we developed the safety efficacy of myrlimax capsules in comparison with etoricoxib. A total of 30 male and female subjects of age between 40 and 75 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-ggenerated randomization list. The subjects will be assigned to either one of the study groups (myrlimax capsule or etoricoxib). The participants will be instructed to take capsules daily in the morning and evening for 30 days. Apart from primary and secondary outcomes, the study will also record vital signs and adverse events to evaluate herbal composition safety and tolerability. The safety assessment of myrlimax capsules will also include routine laboratory investigations on blood, urine, and clinical chemistry at screening and the final visit of the investigation. |