| CTRI Number |
CTRI/2025/05/087256 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Local application of Shukti bhasma to stop haemorrhage |
|
Scientific Title of Study
|
Effect of Shukti Bhasma Pratisaran/Avachurnan to stop Capillary haemorrhage & Venous haemorrhage in any external haemorrhagic conditions in
comparison with Hemocoagulase enzyme topical solution (Botroclot) in the age group
of 10 to 80 yrs |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhushan Baliram Kasbe |
| Designation |
PG Scholar (Shalyatantra) |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya, Department of Shalya tantra OPD no 05
Arni road,
Shivaji nagar,Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9158166627 |
| Fax |
|
| Email |
princebhushan358@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxminiwas R Soni |
| Designation |
Professor and HOD Shalyatantra department, MD (Shalya) & PG Guide |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya, Department of Shalya tantra OPD no 05
Arni road,
Shivaji nagar,Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9422281424 |
| Fax |
|
| Email |
lrsoni10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhushan Baliram Kasbe |
| Designation |
PG Scholar (Shalyatantra) |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Yavatma |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya, Department of Shalya tantra OPD no 05
Arni road,
Shivaji nagar,Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9158166627 |
| Fax |
|
| Email |
princebhushan358@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Shivaji
nagar, Aarni road, Yavatmal 445001 |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with
L.K.Ayurved Rugnalaya, Department of Shalyatantra, Ground floor
OPD No.05, Shivaji Nagar,Yavatmal, Aarni road Dist.Yavatmal
445001 |
| Type of Sponsor |
Other [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 Bhushan Baliram Kasbe |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
OPD NO.05
Department of
Shalyatantra,
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and
L.K.Ayurved Rugnalaya
Shivaji nagar, Aarni road,
Yavatmal 445001
Yavatmal
MAHARASHTRA
Yavatmal
MAHARASHTRA |
9158166627
princebhushan358@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, D.M.M. Ayurved Mahavidyalaya, Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Ayurveda Condition: RAKTASRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | hemocoagulase enzyme | An enzyme called batroxobin is extracted from the venom of Bothrops species vipers. Works on fibrinogen to create a fibrin 10 monomer, which thrombin can then use to create a fibrin clot. A preparation titled Hemocoagulase comprises batroxobin and a factor-X activator. As a haemostatic, Hemocoagulase is used to treat primary, secondary, and postoperative internal and external bleeding
For bleeding follow-up will be taken on every minute for the first 10 min then every 2 min for the next 10 min & then every 5 min till 30 min after 1hr, 6hrs, 24hrs, 48hrs. After 48hrs if there is no bleeding follow-up will be taken after 1 week | | 2 | Intervention Arm | Procedure | - | raktastaMbhan | (Procedure Reference: su. saM. 14/39,40, Procedure details: The clotting time will be noted after the dusting of Shukti Bhasma a 2mm thick layer over the bleeding site. Apart from haemostasis, other effects like discoloura tion, burning, tingling and warmth at the site of bleeding will be assessed. For bleeding follow-up will be taken on every minute for the first 10 min then every 2 min for the next 10 min & then every 5 min till 30 min after 1hr, 6hrs, 24hrs, 48hrs. After 48hrs if there is no bleeding follow-up will be taken after 1 week)
(1) Medicine Name: Shukti, Reference: su. saM. 14/36, Route: Topical, Dosage Form: Bhasma, Dose: 1(g), Frequency: sos, Duration: 1 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.The patients have any external capillary or venous haemorrhage from
wounds resulting due to surgery or trauma on the whole body
2.Patients with ongoing antiplatelet or anticoagulant therapy like aspirin,
clopidogrel, warfarin and heparin will also be included.
3.Patients irrespective of gender, religion, marital status and socioeconomic
class will be selected
4.Patients who will give their consent to participate. |
|
| ExclusionCriteria |
| Details |
1. The patients pre-diagnosed with bleeding disorders such as Haemophilia
or Von Willebrand disease, sickle cell disease, anaemia (Hb less than 8gm),
thrombocytopenia, who require BT, who have just received BT. who need
emergency surgical care and shock will be excluded.
2. Patients with arterial bleeding or associated arterial bleeding.
3. Patients with other systemic diseases such as AIDS, HBsAg, TB, Uncon
trolled Diabetes, Uncontrolled Hypertension, Malignancy, Leprosy and
STDs.
4. Dagdha Vrana.
5. Ulcers with no bleeding.
6. Patients with wounds due to any animal or insect bite.
7. Pregnant and lactating mother.
8. Patients with addictions specifically alcohol, tobacco & smoking. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The clotting time will be noted after the dusting of Shukti Bhasma a 2mm thick
layer over the bleeding site. |
every minute for the first 10 min then
every 2 min for the next 10 min & then every 5 min till 30 min after 1hr, 6hrs,
24hrs, 48hrs. After 48hrs if there is no bleeding follow-up will be taken after 1
week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Apart from haemostasis, other effects like discoloura
tion, burning, tingling and warmth at the site of bleeding will be assessed. |
every minute for the first 10 min then
every 2 min for the next 10 min & then every 5 min till 30 min after 1hr, 6hrs,
24hrs, 48hrs. After 48hrs if there is no bleeding follow-up will be taken after 1
week. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/05/2026 |
| 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
|
This study is randomized trail comparing the efficacy and safety of shukti bhsasma and haemocoagulase solution for haemostasis of capillary and venous haemorrhage in 35 patients of each group that will be conducted in India. |