| CTRI Number |
CTRI/2025/04/085699 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VAAIVIDANGA CHOORANAM (INTERNAL MEDICINE) AND VAAIVIDANGA CHOORANAM (INTERNAL MEDICINE) WITH SIDDHAR YOGA MURAIGAL IN THE MANAGEMENT OF VATHASTHAMBAM (SCIATICA) |
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VAAIVIDANGA CHOORANAM (INTERNAL MEDICINE) AND VAAIVIDANGA CHOORANAM (INTERNAL MEDICINE) WITH SIDDHAR YOGA MURAIGAL IN THE MANAGEMENT OF VATHASTHAMBAM (SCIATICA) |
| 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 K SRI ELAMATHI DEVASENA |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI, TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8870827729 |
| Fax |
|
| Email |
devasena.kasivel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M SANKARA RAMA SUBRAMANIAN MD SIDDHA |
| Designation |
LECTURER GRADE II |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
LECTURER GRADE II, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443465683 |
| Fax |
|
| Email |
srmsrs2873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M SANKARA RAMA SUBRAMANIAN MD SIDDHA |
| Designation |
LECTURER GRADE II |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
LECTURER GRADE II, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443465683 |
| Fax |
|
| Email |
srmsrs2873@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
|
|
Primary Sponsor
|
| Name |
DR SRI ELAMATHI DEVASENA K |
| Address |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Type of Sponsor |
Other [SELF] |
|
|
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 K SRI ELAMATHI DEVASENA |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
SECOND YEAR, DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYMKOTTAI
Tirunelveli
TAMIL NADU |
8870827729
devasena.kasivel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VAAIVIDANGA CHOORANAM (INTERNAL MEDICATION) |
VAAIVIDANGA CHOORANAM 5 – 10 GRAMS, TWICE DAILY WITH ADJUVANT LUKE WARM WATER AS INTERNAL MEDICINE FOR A PERIOD OF 48 DAYS |
| Comparator Agent |
VAAIVIDANGA CHOORANAM (INTERNAL MEDICATION) AND SIDDHAR YOGA MURAIGAL |
VAAIVIDANGA CHOORANAM 5 – 10 GRAMS, TWICE DAILY WITH ADJUVANT LUKE WARM WATER AS INTERNAL MEDICINE AND
PRANAYAAMAM, BHUJANGASANAM,TADASANAM,MAKARASANAM,SAVASANAM, SUPTA MATSYENDRASANAM AS SIDDHAR YOGA MURAIGAL FOR A PERIOD OF 48 DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Herniated disc, Lumbar intervertebral disc bulge, Lumbar or Pelvic muscular spasm, Patient willing to sign Informed consent document, Patient who are willing for admission and stay in IPD or willing to attend OPD.
|
|
| ExclusionCriteria |
| Details |
Spondylolisthesis, Conus medullaris syndrome, Cauda equina syndrome, Sacroiliitis, Congenital anomalies, Pregnant women and Lactating mothers, Patients with any other serious systemic diseases, Patients who face difficulties to practice Siddhar Yoga Muraigal
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Through this trial, the therapeutic effectiveness of the trial drug and Siddhar Yoga Maruthuva Muruaigal towards the management of Vathasthambam (Sciatica) can be manifested. |
48 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative Assessment of change from base line lower back pain with Rolandmorris disability index between Group I and Group II will be achieved. Preference of Yogic Management as line of treatment for Vathasthambam can be acknowledged. |
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 2 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is an open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of,
A. INTERNAL MEDICATION
1. Vaaividanga Chooranam
Dosage: 5 to 10 grams twice a day with Luke Warm Water, after food administered to Group A containing 20 participants for a period of 48 days
B. INTERNAL MEDICATION AND SIDDHAR YOGIC INTERVENTIONS
Synergistic effect of the INTERNAL MEDICATION Vaaividanga Chooranam along with SIDDHAR YOGIC INTERVENTIONS including Pranayamam, Salabhasanam, Sedhu Bandhasanam, Bhujangasanam, Tadasanam, Makarasanam and Savasanam to Group B containing 20 participants for a period of 48 days |