| CTRI Number |
CTRI/2023/06/053623 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
23/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the effect of PK-SHRI herbal cream in managing Acute traumatic wounds-A pilot clinical study |
|
Scientific Title of Study
|
An Open-label single arm pilot clinical study to evaluate the effect of PK-SHRI herbal cream in managing Acute traumatic wounds. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJHareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation
PankajakasthuriAyurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
Pin-695572
India
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director Research and Development |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation Pankajakasthuri
Ayurveda Medical college and PG centre Kattakkada Trivandrum
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
09188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director Research and Development |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation Pankajakasthuri
Ayurveda Medical college and PG centre Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
09188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
echnology Bhavan, New Mehrauli Road,, New Delhi-110 016. |
| Type of Sponsor |
Government funding agency |
|
|
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 Sheeja Chandran |
Pankajakasthuri Ayurveda Medical College |
The Department of Agadatantra,
Second floor, Room No: 2, Pankajakasthuri Ayurveda Medical College and PG centre, Kattakada P.O, Thiruvananthapuram, Kerala, India
Thiruvananthapuram
KERALA |
9497590843
sheeja1arun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Pankajakasthuri Herbal Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80-L99||Other disorders of the skin and subcutaneous tissue. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: PK-SHRI CREAM, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: As the cream dries, it should be applied again and again over the site. If the wound earlier than the schedule day, then application of medicine can be terminated |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. 1.Adults of age group between 18-70 years of either gender with Acute traumatic wound presenting with classical signs and symptoms.
2. 2. Patients willing to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from chronic acute traumatic wounds, varicose ulcers, Diabetic ulcers, lepromatous ulcers, syphilitic ulcers, skin malignancies, and known HIV.
2. Acute traumatic wounds occurring on head, face, breast, perinium.
3. Pregnant and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of PK-SHRI herbal cream in managing Acute traumatic wounds by accessing Burning, Colour, Tenderness
Swelling, margin and scar. |
Burning, Colour, Tenderness
Swelling Will be assessed on 0th 7th & 14th day.
Scar will be assessed on 28th & 45th day.
Margin will be assessed on 0th 7th 14th 28th and 45th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to check the effect of PK-SHRI herbal cream in managing in pain & inflammation |
Will be assessed on 0th & 7th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/06/2023 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Any physical injuries
resulting in a breakage of the skin are known as wounds which can be
categorized into two types namely: acute and chronic wounds. Ideal healing of
the wounds is necessary to restore the normal functioning of the skin. There
are several medications available to manage the wounds. The World Health
Organization is also encouraging the use of traditional medicines in developing
countries as these are cheaper than synthetic drugs and also have minimal side
effects on the patient. In this study, we will
formulate herbal cream from the extracts of Aristolochia indica, Andrographis
panicualta, Commiphora caudata, Chloroxylon swietenia &Tridax
procumbens based on the results obtained from in-vivo studies. The plants selected for formulating the herbal
formulations have significant antibacterial, immunomodulatory and
anti-inflammatory activities, which are complementary to the wound healing
process. The growing popularity of natural and herbal medications, the easy
availability of raw materials, cost-effectiveness and the paucity of reported
adverse reaction, prompted us to formulate a polyherbal topical preparation and
assess its wound healing ability. The combination is used in order to enhance
the wound healing activity |