| CTRI Number |
CTRI/2024/12/078755 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Uloga suttigai for Mugavatham(Bells palsy) |
|
Scientific Title of Study
|
An open single arm clinical trial to determine the therapeutic effect of Uloga suttigai(Metal cauterisation) in the management of Mugavatham(Bells palsy) |
| 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 Selva priya S |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of pura maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai TAMIL NADU 600047 India |
| Phone |
6381749790 |
| Fax |
|
| Email |
selvapriyaselvaraj14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mahadevan M V |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of pura maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai TAMIL NADU 600047 India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mahadevan M V |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of pura maruthuvam
National Institute of Siddha
Tambaram sanatorium
TAMIL NADU 600047 India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Siddha
Tambaram sanatorium-600047 |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium- 600047 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Selva Priya S |
National Institute of Siddha |
Pura maruthuvam OPD,
Ayothidass pandithar Hospital,
National Institute of Siddha
Tambaram sanatorium-600047 Chennai TAMIL NADU |
6381749790
selvapriyaselvaraj14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee, National institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G510||Bells palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Uloga suttigai |
Suttigai is done with heated copper metal probe in the diseased parts at interval of 7 days till 48 days.15-30 minutes per sitting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-60 years
all genders
House brackmann scale grade 2 to 6 |
|
| ExclusionCriteria |
| Details |
uncontrolled diabetes mellitus
pregnant and lactating women
psychiatric disorders
known case of malignancy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the clinical signs & symptoms of Mugavatham(Bells palsy) assessed using house brackamann scale |
Baseline,each week until 7th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life |
Baseline,each week until 7th week |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
10/01/2025 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Siddha system of medicine is
one of the ancient traditional Indian system of medicines with unique
diagnostic methods, therapeutics and treatment procedures. The medicines in Siddha are classified into Agamarunthugal
(Internal medicines) and Puramarunthugal
(External medicines). Suttigai is one of the external therapies which includes uloga suttigai, mann suttigai, mara suttigai, kaanthi
suttigai, kaal suttigai. The metals commonly
used for uloga suttigai are gold, silver,
copper, iron, tin. In uloga suttai the metal probe will be heated and placed in and around the diseased
parts. Bell’s palsy is the most common unilateral and quick-onset
peripheral paralysis of the seventh cranial nerve. Bell’s palsy could be caused
by immune, infectious, or ischaemic causes, although the exact mechanism is not
known. Uloga suttigai (Metal cauterization) is
indicated for Mugavatham in Siddha literature. This study aims to determine the therapeutic effect of Uloga Suttigai (Metal cauterization) by assessing the reduction in clinical
signs and symptoms of Mugavatham (Bell’s
palsy) through House brackmann scale. 20 participants will be recruited for trial and Informed consent will be obtained from each participant. The copper suttigai
instrument will be heated up to red hot and will be touched at the varma points
on the affected site of face, hand, leg and on tender points along the course of facial nerve. It is done at interval of 7 days upto 5 sittings. |