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CTRI Number  CTRI/2025/03/081776 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   To compare the Effectiveness Dietary Protocol along with Clinical Yoga as add on therapy in high blood pressure 
Scientific Title of Study   Effectiveness of Dietary Protocol along with Clinical Yoga as add on therapy in Essential hypertension- Comparative Clinical trial 
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 Sreeni S 
Designation  PG scholar 
Affiliation  VPSV Ayurveda College Kottakkal 
Address  Department of Swasthavritta VPSV Ayurveda College Kottakkal Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  8903789856  
Fax    
Email  sreesavithri27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MC Shobana 
Designation  Professor and HOD 
Affiliation  VPSV Ayurveda College Kottakkal 
Address  Department of Swasthavritta VPSV Ayurveda College Kottakkal Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9446321535  
Fax    
Email  drshobhamc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr MC Shobana 
Designation  Professor and HOD 
Affiliation  VPSV Ayurveda College Kottakkal 
Address  Department of Swasthavritta VPSV Ayurveda College Kottakkal Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9446321535  
Fax    
Email  drshobhamc@gmail.com  
 
Source of Monetary or Material Support  
VPSV Ayurveda College Kottakkal Edarikode P O Kottakkal Malappuram district Kerala 676501 India  
 
Primary Sponsor  
Name  VPSV Ayurveda College Kottakkal 
Address  VPSV Ayurveda College Kottakkal Edarikode PO Kottakkal Malappuram district Kerala 676501 
Type of Sponsor  Other [aided] 
 
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 
Dr SreeniS  VPSV Ayurveda College Kottakkal  Department of Swasthavritta Room NO. A 201 VPSV Ayurveda College Kottakkal Malappuram Kerala
Malappuram
KERALA 		 8903789856

sreesavithri27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) Vaidyaratnam P S Varier Ayurveda college Kottakkal  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: RAKTAVRUTAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: dietary protocol and Yoga , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:dietary protocol is prepared using • Goose berry, Wheat, Brown rice, Lemon, Wheat Rava, Coriander, Finger millet, Green gram, Foxtail millet, Toor Dal • Fruits and vegetables: tender coconut, carrot, tomato, pomegranate, black grapes, banana, dates, snake gourd, plantain stalk, bitter gourd, cucumber, shallots, watermelon, ash gourd, beetroot, lady’s finger , Apathya:Restriction of salt intake up to 5 g / day, less spicy and oily foods, avoidance of fried foods, junk foods, bakery items
2Comparator ArmDrugOther than Classical(1) Medicine Name: sarpagandha tablet , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Those satisfying diagnostic criteria for Grade 1 & 2 hypertension.
2. Age group 30 - 60 years of all gender.
3. Willing to give informed consent
 
 
ExclusionCriteria 
Details  1. Those on modern anti-hypertensives.
2. Known case of DM, Dyslipidemia, CAD, Renal failure, liver disease, other systemic illness.
3. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Systolic and Diastolic blood pressure
Symptom Rating Scale 		 0th, 8th, 15th, 22nd and 31st day and follow up on 46th day 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life questionnaire (MINICHAL).  0th and 31st 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2025 
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 Comparative Clinical Trial is planned to assess the effectiveness of Dietary Protocol based on ayurvedic principles along with clinical yoga in essential hypertension. 40 participants satisfying inclusion criteria will be taken in the study. Both groups will be given Sarpagandha tablet. Participants of Group 1 will be given Dietary Protocol along with Clinical Yoga as add on therapy. Objective parameters assessed will be systolic and diastolic blood pressure and subjective parameters will be Symptoms Rating Scale and Quality of life questionnaire (MINICHAL)  
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