| CTRI Number |
CTRI/2026/02/104679 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Other (Specify) [POTTANAM] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC EFFECTIVENESS OF VENNOCHI POTTANAM (EXTERNAL - MEDICATED POUCH) IN THE MANAGEMENT OF SETHTHUMA THALAINOKKADU [PRIMARY CEPHALGIA] |
|
Scientific Title of Study
|
AN OPEN LABELLED NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC EFFECTIVENESS OF VENNOCHI POTTANAM (EXTERNAL - MEDICATED POUCH) IN THE MANAGEMENT OF SETHTHUMA THALAINOKKADU [PRIMARY CEPHALGIA] |
| 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 JANANI E |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
PG SCHOLAR, DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8610849323 |
| Fax |
|
| Email |
jananie5144@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUJATHA S MDs |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
PROFESSOR AND HEAD OF THE DEPARTMENT, DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUJATHA S MDs |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
| Address |
PROFESSOR AND HEAD OF THE DEPARTMENT, DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET, PALAYAMKOTTAI
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD FACILITIES AND CENTRAL LIBRARY OF GOVERNMENT SIDDHA MEDICALCOLLEGE AND HOSPITAL, PALAYAMKOTTAI ,TIRUNELVELI,TAMILNADU,INDIA ,627002 |
|
|
Primary Sponsor
|
| Name |
DR JANANI E |
| Address |
PG SCHOLAR,DEPARTMENT OF PURA MARUTHHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET, PALAYAMKOTTAI,TIRUNELVELI,TAMIL NADU,INDIA 627002. |
| 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 JANANI E |
GOVERNMENTSIDDHA MEDICALCOLLEGE ANDHOSPITAL,PALAYAMKOTTAI. |
PG SCHOLAR,DEPARTMENT OF PURA MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL,NO 2 LANGAR GANA STREET,PALAYMKOTTAI
Tirunelveli
TAMIL NADU |
8610849323
jananie5144@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
VENNOCHI POTTANAM (EXTERNAL - MEDICATED POUCH) |
VENNOCHI POTTANAM (EXTERNAL - MEDICATED POUCH) - 10-15 MINUTES/ONCE DAILY FOR 14 DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants having pain in forehead, heaviness in head, radiating pain to all over the head region and pain in neck.
Participants having unspecified headache, headache due to sinusitis, cervicogenic headache, unspecified cluster headache, tension headache.
Participants having stiffness/ pain present in cervical region.
Positive radiological findings (X-ray/CT/MRI) for cervical spondylosis.
Participants with mild to severe grades of symptoms.
Participants who are willing to attend OPD and admission to stay in IPD.
|
|
| ExclusionCriteria |
| Details |
Participants with recent H/O trauma, tumours, hemorrhage, fracture and surgery.
Participants with trigeminal autonomic cephalgia.
Participants with H/O cardiac diseases.
Participants with severe disc bulge, disc protrusion, disc herniation of cervical spine.
Tuberculosis of cervical spine, osteomyelitis, autoimmune disorders, any skin lesions etc.,
Pregnancy and lactating women.
Any other serious illness.
Participants who need internal medicines.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to understand the effectiveness of VENNOCHI POTTANAM (EXTERNAL-MEDICATED POUCH) in the management of SETHTHUMA THALAINOKKADU (PRIMARY CEPHALGIA) and Reduction of pain is assessed by clinical assessments. |
14 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess the safety profile of Pottanam therapy.
• To document the basic siddha diagnostic tool Naadi of the participants before and after treatment.
|
14 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)
|
03/03/2026 |
| 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="6"
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 theefficacy ofTRIAL DRUG:
VENNOCHI POTTANAM (EXTERNAL - MEDICATED
POUCH)
EXTERNAL THERAPY:
POTTANAM The drugs used for pottanam are crushed and tied into the cotton cloth
for making proper pouch (kizhi).The medicated
pouch soaked in preheated neem oil is taken for fomentation over the forehead,
around ears, cervical region and in some cases all over the head is involved in
fomentation process for 10-15 minutes.
|