| CTRI Number |
CTRI/2023/08/056714 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial on Varmam therapy, Rasagandhi mezhugu and Ulunthu ennai in the management of Korai Vaatham |
|
Scientific Title of Study
|
A Comparative Randomized clinical trial on Varmam therapy with Rasagandhi Mezhugu(Internal), Ulunthu Ennai (External) and Varmam therapy alone in the management of Korai Vaatham (Lumbar Spondylosis) for the patients reporting at Ayothidoss Pandithar Hospital, National Institute Of Siddha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr E Sasikumar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of siddha |
| Address |
Room no:15
Department of Varma maruthuvam
National Institute of siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8110829457 |
| Fax |
|
| Email |
esasikumar1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N J Muthu kumar |
| Designation |
Professor and Head of the department |
| Affiliation |
National Institute of siddha |
| Address |
Room no:15
Department of Varma maruthuvam
National Institute of siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444206843 |
| Fax |
|
| Email |
njmuthukumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Sasikumar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of siddha |
| Address |
Room no:15
Department of Varma maruthuvam
National Institute of siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8110829457 |
| Fax |
|
| Email |
esasikumar1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of siddha
Tambaram sanatorium
Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute of siddha |
| Address |
Room no:15
Department of Varma maruthuvam
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 E Sasikumar |
Ayothidoss Pandithar Hospital |
Room no:15
Department of Varma maruthuvam
National Institute of siddha
Tambaram sanatorium
Chennai-47
Kancheepuram
TAMIL NADU |
8110829457
esasikumar1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Varmam therapy |
Varmam therapy alone The following Varma points will be given to patients in 7 sittings for 48 days:1.Nattellu varmam 2.Pinsarithi varmam 3.Naavaari ellu varmam 4.Muzhangal mootu mozhiporuthu varmam 5.Kaal komberi kaalam 6.Viruththi varmam 7.Kaal vellai varmam |
| Intervention |
Varmam Therapy with Rasagandhi mezhugu(Internal) and Ulunthu Ennai(External) |
Varmam therapy with Rasagandhi mezhugu(Internal-500 mg, BD with Palm jaggary for 48days) and Ulunthu Ennai(10ml per day- external application for 48days)
The following Varma points will be given to patients in 7 sittings for 48 days:1.Nattellu varmam
2.Pinsarithi varmam
3.Naavaari ellu varmam
4.Muzhangal mootu mozhiporuthu varmam
5.Kaal komberi kaalam
6.Viruththi varmam
7.Kaal vellai varmam
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
1.H/O Ankylosing spondylitis
2.H/O Pott’s spine
3.Traumatic history of the spine
4.Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2023 |
| Date of Study Completion (India) |
06/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
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 with
the Lumbar spondylosis in modern science.The trial drug Rasagandhi mezhugu is a Siddha formulation
mentioned in the literature “Pulipani vaithyam 500†and
the trial drug Ulunthu ennai is a Varma formulation mentioned in Varma classic text “Varma odivu murivu
sara soothiram 1200â€. Most of the ingredients of Rasagandhi mezhugu and Ulunthu ennai have Anti-inflammatory, Analgesic activity and muscle
relaxant properties. Many clinical research studies showed that Varmam as an effective and potential
therapy to alleviate musculoskeletal disorders. OBJECTIVE
To
compare the therapeutic effectiveness of Varmam therapy with Rasagandhi
Mezhugu (Internal), Ulunthu Ennai (External) and Varmam therapy
alone in the management of Korai Vaatham (Lumbar spondylosis) using Oswestry
Disability Index [ODI] and Visual Analogue Scale.
METHODOLOGY Korai vaatham patients fulfilling the inclusion criteria will be
included in the trial. Informed
consent will be obtained from the enrolled patients. Investigations will be carried
out before and at the end of the
trial. 40 patients will be recruited for the trial from the OPD of Ayothidoss
Pandithar Hospital.
Among
40 patients, 20 patients (Group-I) will be treated
with Varmam therapy alone and will be adviced to visit every 7days. 20 patients (Group-II) will be
treated with Varmam therapy with Rasagandhi Mezhugu(Internal), Ulunthu
Ennai (External). The patients
will be advised to visit every 7days, in the Varma Maruthuvam
Department a week for the Varmam therapy and Principal investigator of the study to ensure the
credibility and quality of the study
for 48 days under the supervision of Guide and Head of the Department. The
Laboratory Investigation will be done before and after treatment. At every 7 days clinical assessment will
be done and prognosis noted for 48 days. At the end of the treatment, the patients will be advised to visit the OPD for further 48
days for follow-up. RESULTS The results will be statistically analyzed. KEY WORDS: Korai Vaatham, Varmam, Rasagandhi mezhugu, Ulunthu Ennai, Lumbar spondylosis |