| CTRI Number |
CTRI/2024/07/069805 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| 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 Siddha Medicine Devatharu Kattai Choornam and Siddhar Yoga Muraigal in the Management of Peenism (Sinusitis) |
|
Scientific Title of Study
|
An Open Labelled Triple Arm Non Randomized Phase II Clinical Trial, To Evaluate The Efficacy
Of Sidda Medicine Devatharu kattai Choornam And Siddhar Yoga Muraigal In The Management Of Peenism (Sinusitis) |
| 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 A SAFEEQ AHAMED |
| Designation |
PG SCHOLAR |
| Affiliation |
Government siddha medical College and hospital Palyamkottai |
| Address |
Second Year
Department of Siddhar Yoga
Maruthuvam
Government Siddha Medical College and Hospital
Palyamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8903812120 |
| Fax |
|
| Email |
drahmadsafee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V MAHALAKSHMI MD SIDDHA |
| Designation |
PROFESSOR |
| Affiliation |
Government siddha medical College and hospital Palyamkottai |
| Address |
Head of The Department
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College And Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR V MAHALAKSHMI MD SIDDHA |
| Designation |
PROFESSOR |
| Affiliation |
Government siddha medical College and hospital Palyamkottai |
| Address |
Head of The Department
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College And Hospital
Palayamkottai
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd And Ipd Facilities And Central Library Of Government Siddha Medical College And Hospital , Palayamkottai , Tirunelveli , Pin 627002 ,Tamilnadu , India |
|
|
Primary Sponsor
|
| Name |
DR A SAFEEQ AHAMED |
| Address |
Pg Scholar , Second Year
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai , Tirunelveli , Pin 627002
Tamilnadu
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 A SAFEEQ AHAMED |
Government Siddha Medical College and Hospital |
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College And Hospital
Palayamkottai
627002
Tirunelveli
TAMIL NADU |
8903812120
drahmadsafee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICAL COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI, TIRUNELVELI - 627002, TAMILNADU, INDIA. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Devatharu kattai Choornam |
3 TO 5 Grams Twice Daily With Luke Warm Water for 48 Days |
| Intervention |
Devatharu Kattai Choornam and Vazhalai Kalatral , Bhramari Pranayamam |
Internal Medicine and Siddhar Yoga Muraigal for a Period of 48 Days |
| Comparator Agent |
Vazhalai Kalatral , Bhramari Pranayamam |
Period of 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from acute, sub acute and chronic sinusitis.
Patients having signs and symptoms of Sneezing, Running nose, Nasal congestion, Headache or heaviness of head, Lacrimation, Facial pain, Ear pain and Nasal discharge.
Patients who are willing to give radiological investigation and provide blood for lab investigation.
Patient who are 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 |
History of tuberculosis
History of Bronchial asthma
Fractures & Tumors of nose
History of Epilepsy
History of Psychiatric illness
Patients with any other serious illness
Patient who face difficulties to practice siddhar yoga muraigal are excluded ï‚· Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of the Practises of Siddha Yoga Muraigal (A.Vazhalai Kalatral , B.Brahmari Pranayamam ) and Internal Medicine (Devatharu kattai chooranam) in the management of Peenisam
(Sinusitis).
|
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The positive impact of the synergistic effect of Internal medicine (Devatharu Kattai Chooranam) along with Siddhar Yoga muraigal (A.Vazhalai Kalattral , B.Brahmari Pranayamam) in the management of Peenism (Sinusitis) may be highlighted through this study. |
48 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/07/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
Modification(s)
|
It is an open labelled triple arm non Randomized phase ll clinical trial to evaluate the efficacy of ,A.INTERNAL MEDICATION 1.Devatharu kattai choornam Dosage : 3 to 5 grams twice a day with Luke warm water , before food administered to Group A containing 20 participants for a period of 48 days.
B.SIDDHAR YOGIC INTERVENTIONS 1.Vazhalai kalattral and 2.Bhrammari pranayamam administered to Group B containing 20 participants for 48 days
C. SYNERGISTIC EFFECT Synergistic effect of THE INTERNAL MEDICATION along with SIDDHAR YOGIC INTERVENTIONS to Group C containing 20 participants for a period of 48 days |