A clinical trial on Varmam therapy, Rasagandhi mezhugu and Ulunthu ennai in the management of Korai Vaatham
- Conditions
- Other spondylosis,
- Registration Number
- CTRI/2023/08/056714
- Lead Sponsor
- National Institute of siddha
- Brief Summary
**BACKGROUND:**
According to *Siddha* classic text *Yugi Muni Vaithiya Kaaviyam;Korai Vaatham* is one of the Vaatha diseases.The signs and symptoms of *Korai Vaatham* may be correlated withthe Lumbar spondylosis in modern science.The trial drug *Rasagandhi mezhugu*is a *Siddha* formulationmentioned in theliterature “*Pulipani vaithyam 500*â€andthe trial drug *Ulunthu ennai is a* *Varma* formulation mentioned in *Varma* classic text “*Varma odivu murivusara soothiram 1200â€*. Most of the ingredients of *Rasagandhi mezhugu* and *Ulunthu ennai* have Anti-inflammatory, Analgesic activity and musclerelaxant properties. Many clinical research studies showed that *Varmam* as an effective and potentialtherapy to alleviate musculoskeletal disorders.
**OBJECTIVE**
Tocompare the therapeutic effectiveness of *Varmam* therapy with *RasagandhiMezhugu* (Internal), *Ulunthu Ennai* (External) and *Varmam* therapyalone in the management of *Korai Vaatham* (Lumbar spondylosis) using OswestryDisability Index [ODI] and Visual Analogue Scale.
**METHODOLOGY**
*Korai vaatham* patients fulfilling the inclusion criteria will beincluded in the trial. Informedconsent will be obtained from the enrolled patients. Investigations will be carriedout before and at the end of thetrial. 40 patients will be recruited for the trial from the OPD of AyothidossPandithar Hospital.
Among40 patients, 20 patients (Group-I) will be treatedwith *Varmam* therapy aloneand will be adviced to visit every 7days. 20 patients (Group-II) will betreated with *Varmam* therapy with *Rasagandhi Mezhugu*(Internal), *UlunthuEnnai* (External)*.* The patientswill be advised to visit every 7days, in the Varma MaruthuvamDepartment a week for the *Varmam* therapy and Principal investigator of the study to ensure thecredibility and quality of the studyfor 48 days under the supervision of Guide and Head of the Department. TheLaboratory Investigation will be done before and after treatment. At every 7 days clinical assessment willbe done and prognosis noted for 48 days. At the end of the treatment, the patients will be advised to visit the OPD for further 48days for follow-up.
**RESULTS**
The results will be statistically analyzed.
**KEY WORDS:***Korai Vaatham, Varmam, Rasagandhi mezhugu, Ulunthu Ennai*, Lumbar spondylosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
- 1.Presence of any two or more clinical features of the following: pain in the middle and low back region, difficulty in bending forward and to maintain upright position, stiffness around the hip, pain in upper and lower limbs, Pain aggravates by movements of limbs often preventing from walking or maintaining erect position.
- 2.Patients included using ODI scale 3.Patients who are willing to give radiological investigation (if needed) and provide blood sample for lab investigation 4.Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can option out of the trail of his/her own conscious discretion.
1.H/O Ankylosing spondylitis 2.H/O Pott’s spine 3.Traumatic history of the spine 4.Pregnant women and lactating mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The therapeutic effectiveness of Varmam therapy along with Rasagandhi mezhugu, Ulunthu ennai & Varmam therapy alone in the management of Korai Vaatham (Lumbar Spondylosis) will be assessed using ODI & VAS. 18 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ayothidoss Pandithar Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Ayothidoss Pandithar Hospital🇮🇳Kancheepuram, TAMIL NADU, IndiaDr E SasikumarPrincipal investigator8110829457esasikumar1997@gmail.com