| CTRI Number |
CTRI/2025/02/079959 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of the effectiveness and safety of wound healing herbal ointment for skin wounds |
|
Scientific Title of Study
|
A Randomized, Open- Label, Controlled Pilot Study to Evaluate the Efficacy and safety of wound Healing Herbal Ointment in Healthy Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TG/CLI/087 B |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rajendra Narayan Sharma |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
# 467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, Bangalore-560083
Bangalore
KARNATAKA
560083
India |
| Phone |
09740199006 |
| Fax |
|
| Email |
dr.r.n.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Rajendra Narayan Sharma |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
# 467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, Bangalore-560083
Bangalore
KARNATAKA
560083
India |
| Phone |
09740199006 |
| Fax |
|
| Email |
dr.r.n.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO representative |
| Affiliation |
TrialGuna Private Limited |
| Address |
# 467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, Bangalore-560083
Bangalore
KARNATAKA
560083
India |
| Phone |
09972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| University of Pretoria
Plant Sciences Complex, Office 3-39 Medicinal Plant Science (Department of Plant and Soil
Science) University of Pretoria
Pretoria 0002, South Africa |
|
Primary Sponsor
Modification(s)
|
| Name |
University of Pretoria |
| Address |
Plant Sciences Complex, Office 3-39 Medicinal Plant Science (Department of Plant and Soil
Science) South Africa |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Narayan Sharma |
TrialGuna Private Limited |
# 467,1st Main, 4th Cross, Royal County Layout, JP Nagar 8th Phase, 2nd block, Bangalore-560083
Bangalore
KARNATAKA |
9740199006
dr.r.n.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female subjects aged 18 to 50 years with superficial and partial thickness acute skin wounds |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aloe Wound cream |
1. Aloe arborescens Miller extract- 5%
2.Tea tree essential oil –2%
3. Lavender essential oil- 0.3%
4. Rose hydrosol- 10.2%
5.Dimethicone- 5%
6.Cyclomethicone- 5%
7.Saliguard BDHA- 0.8%
8.Ceramide 3- 4%
9.Polyacrylate crosspolymer-6 – 3%
10. Distilled Water- 64.7%
Frequency: Twice daily
Duration: 14 Days
A thin film of ointment, approximately equivalent to 1 Fingertip unit, should be applied over the wound during each application. |
| Comparator Agent |
Betadine 5% ointment |
Povidone- Iodine IP -5%
Frequency: Twice daily
Duration: 14 Days
A thin film of ointment, approximately equivalent to 1 Fingertip unit, should be applied over the wound during each application. |
| Comparator Agent |
Placebo Wound Cream |
1. Tea tree essential oil- 2%
2. Lavender essential oil – 0.3%
3. Rose hydrosol -10.2%
4. Dimethicone – 5%
5.Cyclomethicone –5%
6. Saliguard BDHA –0.8%
7. Ceramide- 3%
8. Polyacrylate crosspolymer-6 –3%
9. Distilled water –69.7%
Frequency: Twice daily
Duration: 14 Days
A thin film of ointment, approximately equivalent to 1 Fingertip unit, should be applied over the wound during each application. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects aged 18 to 50 years with acute wounds (occurring within the last 24 hours).
2. Subjects with superficial and partial thickness skin wounds up to 1 cm depth and 5 cm length.
3. Subjects ready to receive a tetanus toxoid (TT) injection before the application of the study drug at the discretion of the principal investigator (PI).
4. Subjects who agree to have their wound photographed during the trial.
5. Subjects willing to attend all required study visits. |
|
| ExclusionCriteria |
| Details |
1. Subjects with infected wounds.
2. Individuals with visceral, bony, or spinal injuries.
3. Individuals with electrical, chemical, or burn injuries.
4. Subjects suffering from systemic diseases such as Diabetes mellitus, tuberculosis, malignant wounds, arterial or varicose ulcers, pressure ulcers, HbsAg positivity, HIV I & II positivity, or other conditions deemed by the investigator to potentially interfere with or delay the wound healing process.
5. Subjects with non-healing wounds/ulcers or infectious diseases.
6. Subject on any investigational drug(s) or therapeutic device(s) within 28 days preceding randomization. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of wound healing over the study period using Bates- Jensen Wound Assessment Tool
2. Assessment of the reduction in clinical symptoms of wound
3. Reduction of pain from baseline to end of the study
4. Assessment of time (number of days) required to achieve complete wound closure verified through photo documentation |
Day 1, Day 7, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of skin tolerability throughout the study
2. Incidence of secondary infections during the study period
3. Change in vital signs from baseline to end of the study
4. Change in hematological (CBC), renal function, liver function and urinalysis parameters from baseline to end of the study
5. Incidence of adverse events and serious adverse events during the study period
6. Assessment of patient satisfaction using self-reported questionnaire |
Day 1, Day 7, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
28/02/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Effective wound management is crucial, as impaired or delayed healing can lead to chronic wounds, infections, and significant morbidity. The use of herbal ointment/cream in wound management is rooted in ancient medical practices, where various plant extracts were applied to wounds to promote healing and prevent infection. Modern research has identified several bioactive compounds in these plants that possess antimicrobial, anti-inflammatory, and regenerative properties, which are conducive to wound healing. The rationale for this study is to scientifically evaluate the efficacy and safety of the Aloe wound cream in comparison to a betadine ointment, a standard treatment for wound care and a placebo cream without Aloe. |