| CTRI Number |
CTRI/2021/09/036341 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
22/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
PANCHATHIKTA KIRUTHAM (INTERNAL)AND KARUNKOZHI THYLAM (EXTERNAL) IN RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF PANCHATHIKTA KIRUTHAM (INTERNAL MEDICINE) AND KARUNKOZHI THYLAM (EXTERNAL MEDICINE) IN THE MANAGEMENT OF UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Mahespriya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no1
Department of maruthuvam
National institute of Siddha
Tambaram sanatorium
Kancheepuram
Tamilnadu
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9942737718 |
| Fax |
22381314 |
| Email |
mahespriya237@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no1
Department of maruthuvam
National institute of Siddha Tambaram sanatorium
Kancheepuram
Tamilnadu
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
|
| Fax |
22381314 |
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Mahespriya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:1,Department of maruthuvam,National institute of Siddha, Tambaram sanatorium,Kancheepuram
Tamilnadu
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9942737718 |
| Fax |
22381314 |
| Email |
mahespriya237@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidosspandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidosspandithar Hospital National Institute of Siddha Tambaram Sanatorium Chennai 47 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Mahespriya |
Ayothidoss Pandithar Hospital |
Room no 1
Department of Maruthuvam
National Institute Of Siddha
Chennai -47
Kancheepuram
TAMIL NADU |
9942737718
22381314
mahespriya237@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug-Panchathikta kirutham
(internal)
Drug- Karunkozhi thylam(external)
|
Drug(internal)-Panchathikta kirutham
Dosage-Kaal palam (8.5gm)
Duration- 45 days
Drug(external) Karunkozhi thylam
Dosage -Required quantity of external application
Duration- 45 days
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age : 20 years-50 years
Sex: Male ,female and transgender
Insidious onset of Polyarthritis in the joints.
Prolonged morning stiffness (for 6 weeks or more)
Swelling of multiple joints involved for 6 weeks or more.
Slow progressive signs of inflammation of joints. E.g. Pain, tenderness, warmth >6 weeks
Symmetrical joint involvement
Swelling especially in interphalangeal joints.
Rheumatoid factor positive or negative.
Patients who are willing to attend OPD or willing for admission IPD.
Patients who are willing to undergo Radiological investigation and other laboratory investigation.
Patient who are willing to sign the informed consent stating that he/ she will consciously stick to the treatment during 48 days but can stop opt out of the trail of his /her own conscious discretion.
|
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating mother
Diabetes mellitus
History of trauma
Any other arthritis
Any other serious systemic illness like Cancer, Cardiac disease.
Systemic complication of Rheumatoid arthritis.
Characteristic deformities of hands and feet in Rheumatoid arthritis.
(Z –deformity, Boutonniere deformity, Swan neck deformity in hands, Hammer toe)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain will be done by Universal pain assessment scale and other clinical signs and symptoms will be assessed by Gradation method |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Laboratory investigations such as RA factor, ESR, CRP, ASO titre, Anti CCP will be assessed before and after treatment.
Secondary outcome will be assessed by comparing the parameters pre and post treatment Envagaithervu, Neikuri and neerkuri , Udal thadhukkal, Uyirthadhukkal, Kaalam etc, in Uthiravatha suronitham patients.
|
12 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/10/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this clinical trial, patients reporting at OPD of Ayothidoss Pandithar Hospital, NIS with the clinical symptoms of UTHIRAVATHA SURONITHAM will be enrolled in the study based on the inclusion and exclusion criteria. The patients enrolled in this study will be informed about the objective of the study, trial drug, possible outcomes in their own language and terms understandable to them. After ascertaining the patient’s willingness, informed consent will be obtained in the consent form. All these patients will be given unique registration card which will contains information regarding patients’ Registration number, Address, Phone number, and Doctors phone number, etc. It can help to report easily if any adverse reactions arise. Complete clinical history, complaints, and duration, examination findings-- all will be recorded in the prescribed case record form. Screening Form- I will be filled up; Form II will be used for recording the patients’ history, clinical examination of signs and symptoms and Form III will be used for laboratory investigations. Patients will be advised to take the trial drug with appropriate dietary advice. On 1 day the patient will be advised to take oil bath with Arakku thylam (required quantity). On 2 nd day the patient will be advised to take purgative medication Agasthiyar kuzhambu- 1 kundri (130 mg) with Inji surasam (Ginger juice) in early morning. On 3 rd day patient will be asked to take Rest. On 4th day onwards the trial drug PANCHATHIKTA KIRUTHAM - kaal palam (8.5 g) will be administrated orally after food twice a day and KARUNKOZHI THYLAM will be applied over the affected joints.After enrolling the patient in the study, a separate file for each patient will be opened and all forms will be filed in the file. Study No. and OPD/ IPD No. will be entered on the top of the file for easy identification. Whenever the study patient visits OPD during the study period, the respective patient file will be taken and necessary recordings will be made at the CRF or other suitable forms. The screening forms will be filed separate. The Data recordings will be monitored for completion by Guide, HOD, Department of Maruthuvam, SRO and the adverse event will be monitored by the members of –Pharma co vigilance of NIS. All forms will be further scrutinized in presence of an investigator by Senior Research Officer for logical errors and incompleteness of data to avoid any bias. No modification in the results is permitted for unbiased reports. All the data will be entered into the computer using MS Access software with macro for logical errors and manually cross-checked for data entry error. Then the data will be exported to STATA/SPSS Software for univariate multivariate analysis. Student ‘t’ test and Paired ‘t’ test and Mantel-Haenszel chi-square test will be performed for determining the significance of a particular effect variableThe trial drug will be given for 45 days. OPD patients will be asked to visit the hospital once in 7 days. At each clinical visit clinical assessment will be done and prognosis will be recorded. For IPD patients the clinical assessment will be recorded daily.The results will be compared at the end of the study. Laboratory investigations will be done on the 0th day and 49th day of the trial. |