| CTRI Number |
CTRI/2025/05/087766 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trail on kushtathy 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 kushtathy chooranam in the management of Thandagavatham (lumbar spondylosis) |
| Trial Acronym |
KTC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A RASHMIANAND |
| 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.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9159396927 |
| Fax |
|
| Email |
rashmianbanandan4158@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGSubash chandran |
| Designation |
Reader |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, PALAYAMKOTTAI |
| Address |
PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli, India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
Siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGSubash chandran |
| Designation |
Reader |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE, PALAYAMKOTTAI |
| Address |
PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli, India
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
Siddhadrgs21@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, PALAYAMKOTTAI, 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 |
| Dr A RASHMIANAND |
Government Siddha Medical College and Hospital |
Op number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli, India
Tirunelveli
TAMIL NADU |
09159396927
rashmianbanandan4158@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE , GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, 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 |
Kushtathy chooranam |
Dosage:2 gs 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.patients presenting with or without radiating pain to lower limb.
3.Difficulty in range of motion.
4.Patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Age less than 30 years and more than 65 years
2.Osteoarthritis of hip
3.Patient undergone spinal surgery
4.TB-spine
5.SLE
6.SLR test
7.Infection
8.Rheumatoid arthritis
9.Fracture of spine
10.Chronic renal and liver disease Patients
11.Pregnancy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the clinical effectiveness of kushtathy chooranam in the management of Thandagavatham (Lumbar spondylosis) |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various Siddha literatures and modern journals for literature review on THANDAGAVATHAM
2.To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status.
3.To perform physicochemical, phytochemical, bio chemical analysis of kushtathy chooranam.
4.To evaluate safety profile for acute and sub-acute toxicity of kUSHTATHY
chooranam.
5.To evaluate pharmacological activities of KUSHTATHY CHOORANAM.
6.To evaluate DHEGI of Thandagavatham patients.
7.To study about the prevalence of THANDAGAVATHAM in relation with diet and lifestyle.
8.To evaluate Siddha parameters (including Envagaithervu, Neerkuri-Neikuri) in THANDAGAVATHAM during trial period.
9.To evaluate modern parametric changes in THANDAGAVATHAM.
10.To assess the quality of life of THANDAGAVATHAM patients.
11.To document Bio statistical analysis.
|
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)
|
12/06/2025 |
| 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 PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF KUSHTATHY CHOORANAM IN THE MANAGEMENT OF THANDAGAVATHAM (LUMBAR SPONDYLOSIS).After purification of the trial drug KUSHTATHY CHOORANAM, is prepared and administered at the dosage of 2 grams with the adjuvant Hot water 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 KUSHTATHY 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 KUHTATHY CHOORANAM ,to evaluate safety profile for acute and sub-acute toxicity of KUSHTATHY CHOORANAM ,to evaluate pharmacological activities of KUSHTATHY 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. |