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CTRI Number  CTRI/2024/07/069909 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The study compare how well the medicinal application over the two site of head works in reducing blood pressure in hypertension with the medicine ksirabala taila and kachuradi curna  
Scientific Title of Study   A Randomized Comparative Clinical Trial to assess the efficacy of Thalam with Kṣīrabalā taila 7 Avarthi and KachÅ«rādi cÅ«rna applied over Bregma versus Obelion in acute Grade 1 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 Leena KT 
Designation  PG Scholar 
Affiliation  VPSV Ayurveda college 
Address  Department of Panchakarma VPSV Ayurveda college Kottakkal Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9544663353  
Fax    
Email  leenakt1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Binitha A 
Designation  Professor 
Affiliation  VPSV Ayurveda college 
Address  Department of Panchakarma VPSV Ayurveda college Kottakkal Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9895201635  
Fax    
Email  drbinithaunni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Binitha A 
Designation  Professor 
Affiliation  VPSV Ayurveda college 
Address  Department of Panchakarma VPSV Ayurveda college Kottakkal Malappuram Kerala 676501 India


KERALA
676501
India 
Phone  9895201635  
Fax    
Email  drbinithaunni@gmail.com  
 
Source of Monetary or Material Support  
VPSV Ayurveda college Kottakkal Edarikode PO Malappuram Kerala Pin 676501 India 
 
Primary Sponsor  
Name  VPSV Ayurveda college Kottakkal 
Address  VPSV Ayurveda college Kottakkal Malappuram Kerala 676501 India 
Type of Sponsor  Other [Aided 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 
Dr Leena KT  Vaidyaratnam P S Varier ayurveda College Kottakkal  OPD Department of Panchakarma Room Number A112 Malappuram Kerala
Malappuram
KERALA 		 9544663353

leenakt1996@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
1Comparator ArmProcedure-talam, तलम् (Procedure Reference: Shyamala.B.kaikulangarayude Arogyakalpadrumam.Trissur.Samarat publisher;p288(74), Procedure details: Talam done over Bregma with Ksheerabala tailam 7 Avarti and Kachuradi curna for 45 minutes, for a duration of one day)
(1) Medicine Name: Kṣīrabalā taila, Reference: Ramniwas sharma, Surendra sharma. Sahasrayogam. Chougamba publication:2019.p 75, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: Kachūrādi cūrna, Reference: Ramniwas sharma, Surendra sharma. Sahasrayogam. Chougamba publication:2019.p 140, Route: Topical, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-talam, तलम् (Procedure Reference: Shyamala.B.kaikulangarayude Arogyakalpadrumm.trissur.Samrat publishers;p288(74), Procedure details: Talam done over obelion with Ksheerabala tailam 7 Avarti and Kachuradi curna for 45 minutes, for a duration of one day)
(1) Medicine Name: Kṣīrabalā taila, Reference: Ramniwas sharma, Surendra sharma. Sahasrayogam. Chougamba publication:2019.p 75, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: Kachūrādi cūrna, Reference: Ramniwas sharma, Surendra sharma. Sahasrayogam. Chougamba publication:2019.p 140, Route: Topical, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Grade 1 HTN
Gender – no discrimination
Participants willing to give informed consent
Participants fit for Thalam 
 
ExclusionCriteria 
Details  Grade 2 & 3 HTN
Patient taking anti-hypertensive medicine
Known case of: Unstable angina, DM, heart and renal failure, liver disease, hyperlipidemia
Pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Blood pressure  During treatment (15min, 30min, 45min)
After treatment (60min) 
 
Secondary Outcome  
Outcome  TimePoints 
Distance from the Nasion to the center of the scalp where the participant’s middle finger touches using a measuring tape, assessed across 100 participants .
 		 At the beginning of study (Within 1 Month) 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
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)   15/07/2024 
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)  Open to Recruitment 
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 trial involving 116 participants with acute Grade 1 hypertension, who will be selected based on European Society of Cardiology Guidelines. The participantswill be randomized into two groups following random number table method. Group A will receive Thalam with Kṣīrabalā taila (7A) and Kachūrādi cūrna at Bregma for 45 minutes and Group B will receive Thalam with Kṣīrabalā taila (7A) and Kachūrādi cūrna at Obelion for 45 minutes. BP will be assessed according to World Health Organization (WHO) guidelines; before, during (15min, 30min,45min) and after treatment (60min) using digital automatic BP monitor.
 
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