PANCHATHIKTA KIRUTHAM (INTERNAL)AND KARUNKOZHI THYLAM (EXTERNAL) IN RHEUMATOID ARTHRITIS
- Conditions
- Rheumatoid arthritis with rheumatoid factor, unspecified,
- Registration Number
- CTRI/2021/09/036341
- Lead Sponsor
- National Institute of Siddha
- Brief Summary
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 1day 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Ayothidoss Pandithar Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Ayothidoss Pandithar Hospital🇮🇳Kancheepuram, TAMIL NADU, IndiaDr S MahespriyaPrincipal investigator9942737718mahespriya237@gmail.com