| CTRI Number |
CTRI/2025/01/078845 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised controlled clinical study to evaluate the efficacy of Ayurvedic formulation in the management of primary hypertension |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the efficacy of Ayurvedic formulation formulation 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 Archi Saraf |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research centre, Pimpri, PUNE |
| Address |
Dr. D. Y. Patil College of Ayurveda and Research centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9602351123 |
| Fax |
|
| Email |
jainarchi19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunvant H Yeola |
| Designation |
M.D. Ph.D. KAYACHIKTSA |
| Affiliation |
Dr. D. Y. Patil College of Ayurveda and Research centre, Pimpri, PUNE |
| Address |
Dr. D. Y. Patil College of Ayurveda and Research centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archi Saraf |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research centre, Pimpri, PUNE |
| Address |
Dr. D. Y. Patil College of Ayurveda and Research centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9602351123 |
| Fax |
|
| Email |
jainarchi19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil college of Ayurved and Research centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Archi Saraf |
| Address |
Dr. D. Y. Patil college of Ayurveda and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India 411018 |
| 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 Archi Saraf |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
OPD NO. 5 And IPD of KAYACHIKITSA department
Dr. D. Y. Patil College of Ayurved and Research centre Pimpri, Pune
Pune
MAHARASHTRA |
9602351123
jainarchi19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCA and RC ISNTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hypertensive |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kwath (Decoction) |
Guduchi + Duralabha + Rakta chandan + Patol + Aragvadha + Shunthi + dhanyak
Dose : 50ml BD
Route of administration: Oral
Duration: 14days |
| Comparator Agent |
Tablet |
Amlodipin 5mg
Frequency : once a day
Route of administration: Oral
Duration : 14days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Systolic Blood pressure - less than 180 mm of Hg more than and equal to 140 mm of Hg
Diastolic Blood pressure - less than 110 mm of Hg more than and equal to 90 mm of Hg
newly diagnosed patients |
|
| ExclusionCriteria |
| Details |
Secondary hypertension
Alcoholic and Drug abusers
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Blood pressure |
14 days with follow ups of 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of primary hypertension like headache, giddiness, fatigue, insomnia, perspiration, palpitation |
14 days with follow ups of 7th and 14th day |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
03/03/2025 |
| 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)
|
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
|
A Randomized Comparative Clinical Study to Evaluate the Efficacy of Ayurvedic formulation in the management of primary Hypertension 25 gm powder of ayurvedic formulation will be given to form decoction in 200 ml of water till 1/4th reduction will administered twice a day (12.5 gm in morning and 12.5 gm in evening ) for 14 days with follow ups of 7th and 14th day |