| CTRI Number |
CTRI/2022/09/046010 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
10/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the
effect of mridhwikadhi kashayam and panchagandha choornam thalam in the management of primary hypertension
|
|
Scientific Title of Study
|
EFFECT OF MRIDHWIKADHI KASHAYA AND PANCHAGANDHA CHOORNAM THALAM IN THE MANAGEMENT OF PRIMARY HYPERTENSION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr APEETHA S |
| Designation |
2nd year Pg scholar |
| Affiliation |
sri jayendra saraswathi ayurveda college and hospital (scsvmv) |
| Address |
Room no 17,department of kaya chikitsa, sri jayendra saraswathi ayurveda college and hospital , nazarathepet, poonamalle , chennai .
Thiruvallur
Tamil nadu 600 123
India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9884460643 |
| Fax |
|
| Email |
abeethasrini95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr APEETHA S |
| Designation |
2nd YEAR PG SCHOLAR |
| Affiliation |
sri jayendra saraswathi ayurveda college and hospital |
| Address |
Room no 17,department of kaya chikitsa, sri jayendra saraswathi ayurveda college and hospital , nazarathepet, poonamalle , chennai .
Thiruvallur
Tamil nadu 600 123
India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9884460643 |
| Fax |
|
| Email |
abeethasrini95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr APEETHA S |
| Designation |
2nd year pg scholar |
| Affiliation |
Sri jayendra saraswathi ayurveda college and hospital |
| Address |
SRoom no 17,department of kaya chikitsa, sri jayendra saraswathi ayurveda college and hospital , nazarathepet, poonamalle , chennai .
Thiruvallur
Tamil nadu 600 123
India
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9884460643 |
| Fax |
|
| Email |
abeethasrini95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri jayendra saraswathi ayurveda college and hospital |
|
|
Primary Sponsor
|
| Name |
Sri jayendra saraswathi ayurveda college and hospital |
| Address |
Sri jayendra saraswathi ayurveda college and hospital, narazathepet, chennai -600123 |
| Type of Sponsor |
Private 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 Suvendu Rout |
Sri jayendra saraswathi ayurveda college and hospital. |
Room 17, Department of kayachikitsa , Nazarathepet, Chennai -600123
Thiruvallur
TAMIL NADU |
9444881980
drsrout@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition:4||Measurement and Monitoring. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MRIDHWIKADHI KASHAYAM, Reference: SAHASRAYOGAM, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | talam, तलमॠ| (Procedure Reference: PANCHAKRMAM ARTHAVA SODHANACHIKITSA, Procedure details: THE PROCEDURE IS APPLICATION OF MEDICINE OVER THE HEAD AT BREGMA WITH APPROPRIATE MEDIUM )
(1) Medicine Name: PANCHAGANDHA CHOORNAM, Reference: YOGAGRANTHAM, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(mg), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Cases with elevated systolic and diastolic blood pressure with possible complaints of
Headache, dizziness , breathlessness, palpitation and insomnia
2. Diagnosed patients of primary hypertension willing to participate and sign the informed consent form will be selected for the study
3. Age between 25-55
4.all genders
|
|
| ExclusionCriteria |
| Details |
1.Coronary artery diseases
2.Congestive heart failure
3.Pulmonary tuberculosis
4.Liver disorders
5.Kidney disorders
6.Spleen disorders
7.Diabetes mellitus & diabetes insipidus
8.Cardiac myopathies
9.Stage 2 hypertension
10.Malignant hypertension and secondary hypertension
11.Pregnant women
12.Patient under anti-hypertensive drugs, drugs- cortico-steroids
13.Patients with hereditary dispositions
14.Other systemic illness
15.Sleshma vikara rogi
16.Cervical pathologies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the blood pressure
and symptoms such as headache, insomnia, dizziness, breathlessness and palpitation.
|
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the blood pressure
and symptoms such as headache, insomnia, dizziness, breathlessness and palpitation.
|
After 4 weeks (28 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 3 |
|
Date of First Enrollment (India)
|
05/10/2022 |
| 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="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It
is estimated that 17.6% of patient with primary hypertension globally live in india.
the increased prevalence of hypertension and pre-hypertension among young
indians is being increasingly reported. there are high prevalence of
hypertension among indian adults, across all age groups. in addition there is a
poor awareness, treatment and control among those with hypertension. also in
more than 95% of the cases specific underlying causes of hypertension is not
found. such patient are known to have primary hypertension. Primary
hypertension accounts 90-95% of adult cases and 2-10% of them have secondary
cause. in contemprory science anti-hypertension drug therapy using thiazide,
β-adrenoceptor antagonists, calcium antagonists, vasodilators, angiotension
converting hormone enzyme inhibitor drugs with or without combinations are
given to combat hypertension. persistant usage of these drugs will lead to
“resistance hypertension†which is followed by serious complications. thus to combat these hazardous steps, some
effective management are needed. Hence this study is
planned to bring out effective management
of primary hypertension with administration of mridhwikadhi kashayam internally
and panchgandha choornam thalam externally |