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CTRI Number  CTRI/2024/02/063194 [Registered on: 27/02/2024] Trial Registered Prospectively
Last Modified On: 10/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To stop the bleeding in cut wounds with the help of Spray prepared from plant Eraka . 
Scientific Title of Study   An Experimental Study to Evaluate the Haemostatic Properties of Eraka Spray for the Management of Incised Bleeding Wound. 
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 Lalita  
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  Parul Institute of Ayurveda, Department of Shalya tantra, 4th floor, Room No. 403, Parul University, Lima, Vadodara, Gujarat, India.

Vadodara
GUJARAT
391760
India 
Phone  9467498549  
Fax  0  
Email  drlalitams@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parikshit shirode 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Parul Institute of Ayurveda, Department of Shalya tantra, 4th floor, Room No. 403, Parul University, Lima, Vadodara, Gujarat, India.

Vadodara
GUJARAT
391760
India 
Phone  9960063588  
Fax  0  
Email  parikshit.shirode260038@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Parikshit shirode 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Parul Institute of Ayurveda, Department of Shalya tantra, 4th floor, Room No. 403, Parul University, Lima, Vadodara, Gujarat, India.

Vadodara
GUJARAT
391760
India 
Phone  9960063588  
Fax  0  
Email  parikshit.shirode260038@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital, Parul Institute of Ayurved. 
 
Primary Sponsor  
Name  Parul Institute of Ayurved. 
Address  Parul Institute of Ayurved, Department of Shalya Tantra, 4th Floor, Room No 403, Parul University, Limda, Vadodara, Gujarat, India. Vadodara GUJARAT 391760 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 LALITA  Parul Ayurved Hospital.  Parul Ayurved Hospital, Department of Shalya tantra, OPD No 106, Ground Floor, Parul University, Limda,Vadodara, Gujarat.
Vadodara
GUJARAT 
9467498549
0
drlalitams@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee -Parul Institute of Ayurved.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: SALYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-SoNitAsthApana-karma, शोणितास्थापन-कर्म (Procedure Reference: ProceduShushrut shamhita , chikitsa sathan 1, shalok 48, Procedure details: Procedure details: The regular gauze dressing is placed with pressure)
2Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal hemostatic spray, Reference: NA, Route: Topical, Dosage Form: Sprays, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 1 Days, Reference: NA, Route: -, Dosage Form: Sprays, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients who are posted for elective surgery under
local /Spinal Anaesthesia.

2.The expected size of the wound is about 3-5 cm or more in length and 1-2 cm or more in width. 
 
ExclusionCriteria 
Details  1.Patient with known history of any co morbidities
2.Those who are under 18 years and above 60 years
3. Patient having known hematalogical disorder
or on anti platelet drugs .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To cease bleeding with herbal agent by means of effective ayurvedic hemostatic spray.  one minute. 
 
Secondary Outcome  
Outcome  TimePoints 
Achieve fast acting herbal haemostatic agent.   one minute 
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
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)   06/03/2024 
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="0"
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
Modification(s)  

Management of effective hemostasis during surgery is one of the major components that provide many benefits to both the surgical team and the patient in terms of early recovery. Hemostasis has been given a lot of focused attention Arresting bleeding in open cut injury is till now a great challenge in medical field, Défense service person who gets injured in the field of war, domestic cuts and injuries, injury to children who fall down while playing forces the mother to rush to a doctor .Haemostasis is the first complex process initiated in response to injury in wound healing.and the First Aid box contains only emergency medicines for pain, Dressing Material and shock management but there is lacuna of product in the box to stop Bleeding. In many Allopathic hospitals we see that liquid Tincture Benzoic is used which simultaneously burning sensation also so severe that often intolerable and moreover it cannot substitute stitches. to provide immediate solution to acute problems of accidental injuries by stopping the blood oozing out from the wounds by this study.

Acharya Susruta has even considered raktadhatu as important as Tridoshas in the etiopathology of diseases, its curative measures and in maintenance of health. He states ‘the life is sustained by proper functioning of blood, and the body itself is rooted to Rakta’.

 

Rakta is life’ hence it is to be protected by any means. Acharya Susruta the father of ancient surgery, was the first to name, classify and describe the Chaturvidha Rakta Sthambhana Upayas.

To be used as per severity and type in the order- Skandana, Sandhana, Dahana,pachana. Furthermore, the medications described in Vranaropaka (boosting wound healing) should be evaluated in terms of hemostasis, as the first stage of wound healing is blood clotting, and these treatments may produce hemostasis initially before promoting wound healing .It is also an Endeavor to provide a better and fast healing formulation obtained from the plant Erak (Typha Eliphantina). This Herbal plant contains haemostatic and coagulant properties with a remarkable wound healing effect.which will aid in better understanding and application for the advancement of the medical sector in the modern day.

Hence the need and uniqueness of study

 
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