| CTRI Number |
CTRI/2020/11/029368 [Registered on: 25/11/2020] Trial Registered Prospectively |
| Last Modified On: |
22/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
VARMAM THERAPY WITH AND WITHOUT KURUNTHOTTI KASHAYAM for the CEGANAVATHAM (CERVICAL SPONDYLOSIS) |
|
Scientific Title of Study
|
A PRECLINICAL AND COMPARATIVE CLINICAL TRIAL OF VARMAM THERAPY WITH AND WITHOUT KURUNTHOTTI KASHAYAM (INTERNALLY) IN THE MANAGEMENT OF CEGANAVATHAM (CERVICAL SPONDYLOSIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishnapriya D |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 3,
Department of varmam maruthuvam,
National Institute of Siddha,
Tambaram sanatorium,
Kancheepuram,
TAMILNADU.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8012634515 |
| Fax |
|
| Email |
krishnadoss14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadevan V |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 3,
Department of sirappu maruthuvam,
National Institute of Siddha,
Tambaram sanatorium,
Kancheepuram,
TAMILNADU.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
mahasiddha2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahadevan V |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 3,
Department of sirappu maruthuvam,
National Institute of Siddha,
Tambaram sanatorium,
Kancheepuram,
TAMILNADU.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
mahasiddha2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss pandithar hospital,National Institute of Siddha, Tambaram sanatorium |
| 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 D Krishnapriya |
Ayothidoss pandithar hospital |
Room no 3, department of var ma maruthuvam, tambaram sanatorium, chennai-47
Kancheepuram
TAMIL NADU |
8012634515
krishnadoss14@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: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Varmam therapy and kurunthotti kashayam |
varmam therapy-48 days weekly thrice( 21 sittings)
kurunthotti kashayam - 3 days (6o ml twice a day) |
| Comparator Agent |
varmam therapy compare to varmam with kurunthotti kashayam |
GROUP A: 20 patients will be treated with both Kurunthotti kashayam and Varmam therapy
GROUP B: 20 patients will be treated only with Varmam therapy
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Pain present behind the neck
Region, aggravated by movement
2. Neck stiffness
3. Difficulty in flexion and extension of neck
4.pain radiating to shoulder blade, top of the shoulder, upper arm and back of the head
5. Dizziness or vertigo
6. Numbness in both upper limb
4. Pain radiating to |
|
| ExclusionCriteria |
| Details |
1. Patient with uncontrolled hypertension
2.pregancy and lactation
3. Cervical rib
4. Spina bifida
5. Ankylosis spondylosis
6. Rheumatoid arthritis
7. Patient with thyroid
8. Any trauma history
9. Loss of bowel and bladder control
10. Dysphagia
11. Fracture in neck region
12. Coronary artery disease
13. Tuberculosis
14. Severe osteoporosis
15. Neck surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| UNIVERSAL PAIN ASSESSMENT SCALE |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the siddha basic principles relevant to the diseases |
48 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/11/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is the comparative two arm clinical study to evaluate the efficacy of varmam therapy with and without kurunthotti kashayam in the management of ceganavatham in 40 patients for 48 days. The outcome will be measured by Universal pain scale and reduction in clinical symptoms. |