| CTRI Number |
CTRI/2026/02/104184 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Dhadimathi Kashayam in the management of Raththa Piththam (Systemic Hypertension ) |
|
Scientific Title of Study
|
A prospective open labelled,single arm,non-randomized,single centric,phase II clinical trial to determine the effectiveness of Dhadimathi Kashayam in the management of Raththa Piththam(Systemic Hypertension) |
| 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 RAM KUMAR M |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital . |
| Address |
OP Number 10 PG Department of Pothu Maruthuvam Government Siddha Medical College And Hospital ,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7867935244 |
| Fax |
|
| Email |
singamuthuram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR G SUBASH CHANDRAN |
| Designation |
PROFESSOR |
| Affiliation |
Government Siddha Medical College and Hospital . |
| Address |
PG Department Of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9345600723 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S JUSTUS ANTONY |
| Designation |
HEAD OFTHE DEPARTMENT |
| Affiliation |
Government Siddha Medical College and Hospital . |
| Address |
OP Number 10 PG Department Of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Government Siddha Medical College and Hospital,Palayamkottai, Tirunelveli –627002, India. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli–627002,India.
|
| 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 RAM KUMAR M |
Government Siddha Medical College and Hospital |
OP Number 10 PG Department Of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai.
Tirunelveli
TAMIL NADU |
7867935244
singamuthuram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College, Palayamkottai,Tirunelveli – 627 002. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DHADIMATHI KASHAYAM |
Dosage-50ml (Twice a day orally),before food for 48 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Known Systemic Hypertension
High Normal (SBP 130-139 mmHg and/or DBP 85-89 mmHg)
Grade 1 Hypertension (SBP 140-159 mmHg and/or DBP 90-99 mmHg)
Grade 2 Hypertension (SBP 160-179 mmHg and/or DBP 100-109 mmHg)
|
|
| ExclusionCriteria |
| Details |
Known Malignant hypertension
Ischemic heart diseases
Chronic kidney disease
Chronic liver disease
Malignancy
Hyperlipidemia
Diabetes mellitus
Smoking and Alcoholism.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome will be aimed at reducing systemic blood pressure.
This will reduce the risk of developing complications from Hypertension.
Patients will adhere to regular BP monitoring, medications and follow up appointments for Hypertension.
The trial drug, DHADIMATHI KASHAYAM, will be justified for its potential effect in the clinical study of management of systemic hypertension. So the trail medicine will be safer to manage in systemic hypertension patients
|
48 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To collect various Siddha literatures and modern journals for literature review on RATHTHA PITHTHAM NOI.
To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status.
To perform physicochemical,phytochemical,bio chemical analysis of DHADIMATHI KASHAYAM.
To evaluate safety profile for acute and toxicity of DHADIMATHI KASHAYAM.
To evaluate pharmacological activities of DHADIMATHI KASHAYAM.
To perform molecular docking studies for ACE inhibitor and Angiotensin receptor blocker activities.
To evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in RATHTHA PITHTHAM NOI during trial period.
To evaluate modern parametric changes in RATHTHA PITHTHAM NOI.
To document Bio statistical analysis.
|
06 MONTHS |
|
|
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)
|
25/03/2026 |
| 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 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
|
This is a prospective open
labelled,single arm, non- randomized ,single centric, phase II clinical trial to determine the
effectiveness of Dhadimathi kashayam in the management of Raththa Piththam
(Systemic Hypertension ).The trial drug Dhadimathi kashayam is freshly prepared
and will be administered at a dosage of 50ml (twice a daily before food )for 48
days for 40 known primary hypertension (20 OP and 20 IP patients ).The primary outcome will be determine the clinical
efficacy of Dhadimathi kashayam (internal) in the management of Raththa
Piththam (Systemic hypertension) .The secondary outcome will be collect the
various siddha literatures and modern journals for literature review on Raththa
Piththam.To study other cofactors related to disease like
age,sex,dietary habits,family history and socioeconomic status .To perform
physiochemical,phytochemical ,biochemical analysis of Dhadimathi Kashayam .To evaluate
the safety profile for acute toxicity for Dhadimathi Kashayam .To evaluate pharmacological activities of Dhadhimathi Kashayam |