| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: SALYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | SoNitAsthApana-karma, शोणितासà¥à¤¥à¤¾à¤ªà¤¨-करà¥à¤® | (Procedure Reference: ProceduShushrut shamhita , chikitsa sathan 1, shalok 48, Procedure details: Procedure details: The regular gauze dressing is placed with pressure)
| | 2 | Intervention Arm | Drug | Other 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, DeÌfense 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 |