| CTRI Number |
CTRI/2026/03/106668 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [VARMA POINT MANIPULATION] |
| Study Design |
Other |
|
Public Title of Study
|
Management of Bronchial Asthma with Varma points manipulation and Internal medicine Muppalai Chooranam |
|
Scientific Title of Study
|
AN OPEN LABELLED DOUBLE ARM NON-RANDOMIZED,PHASE-II CLINICAL TRIAL TO COMPARE THE EFFECTIVENESS OF VARMA POINTS MANIPULATION WITH MUPPALAI CHOORANAM(INTERNAL) IN THE MANAGEMENT OF SWASAKASAM (BRONCHIAL ASTHMA) |
| 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 S KESAVAN |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Op no:14, PG Department of Varma maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9597923776 |
| Fax |
|
| Email |
k7theesh100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S ARUNA MD SIDDHA |
| Designation |
LECTURER |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
PG Department of Varma Maruthuvam, Government Siddha Medical College and Hospital ,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9444206633 |
| Fax |
|
| Email |
arunaram1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R KRISHNAMOORTHI MDS |
| Designation |
Associate Professor and HOD of Department of Varma Maruthuvam |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
PG Department of Varma Maruthuvam, Government Siddha Medical College and Hospital ,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442545017 |
| Fax |
|
| Email |
arksiddh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Governemnt Siddha Medical College and Hospital ,Palayamkottai ,Tirunelveli - 627002 , Tamilnadu , India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital ,Palayamkottai |
| Address |
OP No 14 ,PG Department of Varma Maruthuvam ,Government Siddha Medical College and Hospital ,Palayamkottai , Tirunelveli |
| 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 S KESAVAN |
Government Siddha Medical College and Hospital |
OP no:14 , PG Department of Varma Maruthuvam , Government Siddha Medical college and hospital, Palayamkottai
College and Hospital Palayamkottai -627002
Tirunelveli
TAMIL NADU |
9597923776
k7theesh100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Internal medicine Muppalai chooranam |
2gram of chooranam twice daily with honey for 24 days |
| Intervention |
Varma point manipulation |
Stimulation of specified varma points for 24 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults who are diagnosed with bronchial asthma 2.Patients with a clinical symptoms of swasakasam-recurrent episodes of
wheezing, chest tightness, shortness of breath and dry cough,worse at night or early morning.
3.History of symptoms
triggered by allergens, climatic changes.
4.Patients willing to
provide blood samples for laboratory investigations.
|
|
| ExclusionCriteria |
| Details |
1.Patients with pulmonary Tuberculosis
2.Patients with status asthmaticus
3.Patients with chronic bronchitis, chronic bronchiectasis
4.Patients with heart failure
5.Patients with renal disease
6.Pregnancy and Lactating mothers
7.Diabetes mellitus
8.Hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the severity and frequency of
clinical symptoms of Swasakasam (Bronchial
Asthma), including shortness of breath, chest
tightness, wheezing, and dry cough
|
24 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of Asthma Control Questionnaire
(ACQ) score following treatment
2.Evalaution of absolute eosinophil count
following treatment
|
24 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)
|
01/04/2026 |
| 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 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
|
An open labelled double arm non randomized phase II clinical trial to compare the effectiveness of varma point manipulation with muppalai chooranam( internal) in the management of Swasakasam ( Bronchial asthma). Varma point manipulation will be performed at selected Varma points for 24 days. The dosage of internal medicine Muppalai chooranam is 2 gram twice daily with honey and will be administered for 24 days. The sample size of the study is 40, which will be divided into two groups with 20 participants in each group. First group will be given Varma point manipulation only for 24 days. Second group will be given internal medicine Muppalai chooranam for 24 days |