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CTRI Number  CTRI/2022/09/045143 [Registered on: 01/09/2022] Trial Registered Prospectively
Last Modified On: 01/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Herbal Formulation and Amlodipine in Essential Hypertension  
Scientific Title of Study   Comparative Evaluation of a Herbal Formulation and Amlodipine in Essential 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 Arun Kumar Tripathi 
Designation  Campus Director and Professor Department of Kayachikitsa 
Affiliation  Gurukul campus UAU Haridwar 
Address  Gurukul campus UAU Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9415720013  
Fax    
Email  draruntripathi@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar Tripathi 
Designation  Campus Director and Professor Department of Kayachikitsa 
Affiliation  Gurukul campus UAU Haridwar 
Address  Gurukul campus UAU Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9415720013  
Fax    
Email  draruntripathi@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Kumar Tripathi 
Designation  Campus Director and Professor Department of Kayachikitsa 
Affiliation  Gurukul campus UAU Haridwar 
Address  Gurukul campus UAU Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9415720013  
Fax    
Email  draruntripathi@yahoo.com  
 
Source of Monetary or Material Support  
GURUKUL CAMPUS UAU HARDWAR 
 
Primary Sponsor  
Name  GURUKUL CAMPUS UAU HARDWAR 
Address  OPD NO. 05 DEPARMENT OF KAYACHIKITSA GURUKUL CAMPUS UAU HARDWAR 249404 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Gudiya   Gurukul campus UAU Haridwar  OPD NO.05 PG Department of Kayachikitsa Gurukul campus UAU Haridwar
Hardwar
UTTARANCHAL 		 7398285474

gudiyaradhika77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Gurukul campus UAU Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: Vyanbala Vaishmya,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Herbal Formulation , Reference: ch.chi.1-3/30-31, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Comparator Arm (Non Ayurveda)-AmlodipineIt will be administered orally 5mg OD for 30 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Patients willing to participate in the study.
2)Patients of either sex with age between 18-70 years.
3)Patients having Hypertension between time interval of 6 months to 1 year.
4)Patients suffering from stage 1 Hypertension (SBP140-159mmHg, DBP 90-99mmHg)
5)Patients suffering from Isolated Systolic Hypertension.
 
 
ExclusionCriteria 
Details  1)Patients not willing to participate in the study.
2)Patients of either sex below 18 years & above 70 years will be excluded from the study.
3)Patients having Hypertension for <6 months and >1 year will be excluded.
4)Patients of stage 2 Hypertension (SBP >160mmHg and DBP >100mmHg)
5)Patients suffering from serious comorbidities like Renal failure, Coronary Artery Disease, taking medication/drug (oral contraceptives, steroids, chronic use of NSAIDs etc…)
6)Alcoholic and/or drug abusers.
7)History of hypersensitivity to the trail drugs or any of its ingredients.
8)Pregnant /lactating woman.
9)Patients who have completed participation in any other clinical trail during the past 6 months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in subjective parameters like-
a)Headache (Shiro ruja)
b)Giddiness (Bhrama)
c)Palpitations (hriddrava)
d)Breathlessness (shwasa)






 		 At 1st day,10th day,20th day, and
30th day

 
 
Secondary Outcome  
Outcome  TimePoints 
The objective assessment will be done on the basis of changes in clinical findings & laboratory parameters.
1)Urine
2)CBC
3)RBS
4)Serum creatinine
5)Lipid profile
6)ECG


 		 At 1st day and 30th day 
 
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   N/A 
Date of First Enrollment (India)   02/09/2022 
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="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gudiyaradhika77@gmail.com].

  6. For how long will this data be available start date provided 02-09-2022 and end date provided 02-09-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is randomized control group, open label trial for efficacy of Herbal Formulation (medhya vati).The study wiill be conducted at UAU Gurukul Campus Haridwar in 40 patients. The assessment will be done on the basis of Subjective and Objective parameters. The study will be conducted at OPD/IPD level of PG Department of kayachikitsa. The results will be tabulated and statistically analyzed using appropriate tests.  
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