| CTRI Number |
CTRI/2018/02/012189 [Registered on: 27/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effect of Pankajakasthuri Orthoherb Tablet in patients with pain, swelling and stiffness of joints. |
|
Scientific Title of Study
|
An open clinical trial for the assessment of efficacy of Pankajakasthuri Orthoherb Tablet in patients with osteoarthritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGSSreekumar |
| Designation |
Assistant Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre,Killy,Kattakada, Thiruvananthapuram.
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9486886362 |
| Fax |
0471-2293808 |
| Email |
gssreekumarnair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSreejithSatheesan |
| Designation |
Assistant Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre,Killy,Kattakada, Thiruvananthapuram.
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447791353 |
| Fax |
0471-2293808 |
| Email |
dr.sreejith.satheesan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrARUNPRATAP |
| Designation |
Associate Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Pankajakasthuri
Ayurveda Medical College and Post Graduate Centre, Killy,
Kattakada, Thiruvananthapuram.
Thiruvananthapuram.
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9567256333 |
| Fax |
0471-2293808 |
| Email |
dr.arunpratap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College and Post Graduate
Centre,KILLY, KATTAKADA, THIRUVANANTHAPURAM |
|
|
Primary Sponsor
|
| Name |
PANKAJAKASTHURI AYURVEDA MEDICAL COLEGE AND POST GRADUATE CENTER |
| Address |
Pankajakasthuri Ayurveda Medical College and Post Graduate
Centre,KILLY, KATTAKADA, THIRUVANANTHAPURAM |
| Type of Sponsor |
Other [AYURVEDA MEDICAL COLLEGE AND POST GRADUATE CENTRE IN PRIVATE SECTOR] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ARUNVISAKHS |
Chithramsu kandala.p.o. Thiruvananthapuram
695512 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGSSREEKUMAR |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
Department of KAYACHIKITSA
DIVISION 1
ROOM NUMBER 1
Thiruvananthapuram
KERALA |
9486886362
04712293808
gssreekumarnair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M158||Other polyosteoarthritis, (2) ICD-10 Condition: M159||Polyosteoarthritis, unspecified, The Patients with pain in joints visiting
PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE OUT PATIENT DEPARATMENTS for consultation., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
PANKAJAKASTHURI ORTHOHERB TABLET-500mg |
DOSE:TWO tablets
ROUTE OF ADMINISTRATION:ORAL
FREQUENCY:TWO TIMES PER DAY BEFORE FOOD
TIME:FOR SIX MONTHS |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Classical Signs and Symptoms of Osteoarthritis - Pain during movement and weight bearing, Swelling, Stiffness.
Also fulfilling the classical criteria of Sandhigatavata mentioned in Ayurvedic texts- Shoola i.e. Akunchana prasarana vedana, Shotha and Sthambha. |
|
| ExclusionCriteria |
| Details |
Secondary Arthritic conditons, Fractures, Ligament tear, Dislocation, Osteomyelitis, SLE, Tumors
Bone density disorders, Anatomical joint deformities, NSAID/Analgesic/steroid treatment for Osteoarthritis, Patients who have undergone major surgery in the affected joint.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
More than 80% of participants had 100% relief
Assessment criteria was based on the grading of following parameters
PAIN
STIFFNESS
TENDERNESS
SWELLING.
|
SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
More than 50% of participants got relief of symptoms ranging from MILD to MODERATE.
Assessment criteria was based on the grading of following parameters
PAIN
STIFFNESS
TENDERNESS
SWELLING
|
SPECIFIC TIME FOR ASSESSING SECONDARY OUTCOME : 2 MONTHS |
An average of 60% of participants got MODERATE to CONSIDERABLE relief of symptoms.
Assessment criteria was based on the grading of following parameters
PAIN
STIFFNESS
TENDERNESS
SWELLING |
SPECIFIC TIME FOR ASSESSING SECONDARY OUTCOME : 4 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/05/2016 |
| Date of Study Completion (India) |
16/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Osteoarthritis is a joint disease that mostly affects cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint. This study is a open clinical trial to assess the efficacy of PANKAJAKASTHURI ORTHOHERB TABLET in 500 patients with Osteoarthritis who visited the OPD of PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE HOSPITAL from 25-05-2016 to 16-12-2016. The severity of disease was graded under four scoring scales. The observation and calculations were made on the basis of relevant statistical methods. The primary outcome measure was done at the end of 6th month and secondary outcome was measured at the end of 2nd month and 4th month. The observations on the basis of followup were also taken for statistical analysis. The statistical analysis by using paired t test produced the success rate by attaining P<0.001 shows the medicinal value of the product is highly significant in treating the disease- Osteoarthritis with high percentage of improvement. There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan. There exist remedial measures to treat pain associate with skeletal system in ancient Ayurvedic texts where elaborate descriptions are available. Mainly Vatavyadhi affecting sandhi s were given importance. The form or kalpana differs in accordance with the different conditions of disease pathogenesis. Even though very effective kashayakalpanas are available, the palatability and preservation make its less acceptance among patients. Thus, an effective medicine in the form of ORTHOHERB tablet is tried among the outpatients of Pankajakasthuri Ayurveda Medical College OPD and found effective in treating pain associated with joint disorders by reverting actual sampraptighatakas of the disease process. EFFECT OF TREATMENT ON SIGNS AND SYMPTOMS 1. EFFECT ON PAIN The mean score of the symptoms which was 3.410 before treatment reduced to 2.436 with the mean difference of 0.974 ± 0.574 on the 2nd month after the treatment, which further reduced to 1.102 (mean difference of 3.308 ± 0.605) during 6th month follow up. The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001. 2. EFFECT ON OEDEMA The mean score of the symptoms which was 2.460 before treatment reduced to 1.562 with the mean difference of 0.898 ± 0.303 on the 2ND month after the treatment, which further reduced to 0.000 (mean difference of 2.460 ± 0.711) during 6th month follow up. The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001. 3. EFFECT ON STIFFNESS The mean score of the symptoms which was 3.208 before treatment reduced to 2.208 with the mean difference of 1.000 ± 0.506 on the 2ND month after the treatment, which further reduced to 0.102 (mean difference of 3.106 ± 0.746) during 6th month follow up. The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001. 4. EFFECT ON TENDERNESS The mean score of the symptoms which was 2.616 before treatment reduced to 1.490 with the mean difference of 1.126 ± 0.565 on the 2nd month after the treatment, which further reduced to 0.000 (mean difference of 2.616 ± 0.487) during 6thmonth follow up. The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001. 5. EFFECT ON PAIN ON MOVEMENT
The mean score of the symptoms which was 3.336 before treatment reduced to 2.360 with the mean difference of 0.976 ± 0.482 on the 2nd month after the treatment, which further reduced to 0.102 (mean difference of 3.234 ± 0.767) during 6th month follow up. The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001. From the study it is clearly evident that the trail drug is high significant in managing osteoarthritis and here by declaring that the study was completed and closed.
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