| CTRI Number |
CTRI/2024/06/068547 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial on Komoothira Silasathu Chooranam in the management of Thandagavatham (Lumbar spondylosis) among patients attending OPD and IPD of Government Siddha Medical College and Hospital,Palayamkottai |
|
Scientific Title of Study
|
A prospective open labelled single arm non- randomized single centric phase II clinical trial on Komoothira Silasathu Chooranam in the management of Thandagavatham (Lumbar spondylosis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V SAKTHIPRIYA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
OP number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli,India
Government Siddha Medical College and Hospital,
Tiruvanathapuram main road, Palayamkottai,
Tirunelveli
TAMIL NADU
627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9791543514 |
| Fax |
|
| Email |
sakthipriya6798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S JUSTUS ANTONY |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital,
Tiruvanathapuram main road, Palayamkottai,
Tirunelveli
TAMIL NADU
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli Alias Mehala |
| Designation |
Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital,
Tiruvanathapuram main road, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL
COLLEGE AND HOSPITAL,TIRUVANANTHAPURAM MAIN ROAD, PALAYAMKOTTAI, TIRUNELVELI- 627002, TAMILNADU, INDIA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
PG DEPARTMENT OF POTHU MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,TIRUVANANTHAPURAM MAIN ROAD, PALAYMKOTTAI, TIRUNELVELI,TAMILNADU,INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 |
| V SAKTHIPRIYA |
Government Siddha Medical College and Hospital |
OP number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvanathapuram main road, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU |
9791543514
sakthipriya6798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE,PALAYAMKOTTAI |
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 |
| Intervention |
Komoothira Silasathu chooranam |
DOSAGE:130 mgs twice a day orally for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Pain and stiffness in the lumbar region
2.Patient presenting with or without radiating pain to lower limb
3.Difficulty in range of motion
4.Patient who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Osteoarthritis of hip
2.Patient undergone spinal surgery
3.TB-Spine
4.SLE
5.Infection
6.Rheumatoid arthritis
7.Fracture of spine
8.Chronic renal and liver disease patients
9.Pregnancy and lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing the symptoms of Thandagavatham(Lumbar sponsylosis)and to determine the therapeutic efficacy of clinical trials drug(komoothira silasathu chooranam) |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various aspects of Thandagavatham in Siddha literatures.
2.To evaluate physico chemical,phyto chemical and bio chemical characters of Komoothira Silasathu chooranam.
3. To evaluate safety profile for assessing acute and sub-acute toxicity of trial drug Komoothira Silasathu chooranam.
4.To evaluate pharmacological analysis of Komoothira Silasathu chooranam.
5.To Study about the prevalence of Thandagavatham in relation between diet and life style.
6.To evaluate siddha parameters (including Envagai thervu) changes and dhegi of Thandagavatham patients during the study period.
7. To evaluate modern parametric changes in Thandagavatham patients
8.To document the Bio statistical analysis.
9. To assess the Quality of life of Thandagavatham patients. |
6 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF KOMOOTHIRA SILASATHU CHOORANAM IN THE MANAGEMENT OFTHANDAGAVATHAM (LUMBAR SPONDYLOSIS).After purification of the trial drug KOMOOTHIRA SILASATHU, chooranam is prepared and administered at the dosage of 130mgs with the adjuvant Elathy kudineer for 48 days,which is given to 40 known lumbar spondylosis patient( 20 OP and 20 IP patients). The primary outcome will be to determine the therapeutic efficacy of KOMOOTHIRA SILASATHU CHOORANAM in the management of Thandagavatham (lumbar spondylosis ).The secondary outcome will be to collect various Siddha literatures on THANDAGAVATHAM, ,to perform physicochemical, phytochemical, bio chemical analysis of KOMOOTHIRA SILASATHU CHOORANAM ,to evaluate safety profile for acute and sub-acute toxicity of KOMOOTHIRA SILASATHU CHOORANAM,to evaluate pharmacological activities of KOMOOTHIRA SILASATHU CHOORANAM,to study about the prevalence of THANDAGAVATHAM in relation with diet and lifestyle,to evaluate Siddha parameters (including Envagaithervu, Neerkuri-Neikuri) changes and dhegi of THANDAGAVATHAM patients during trial period,to evaluate modern parametric changes in THANDAGAVATHAM,to assess the quality of life of THANDAGAVATHAM patients and to document Bio statistical analysis.
|