| CTRI Number |
CTRI/2017/10/010150 [Registered on: 23/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of C1 Herbal oil healing properties in skin wounds |
|
Scientific Title of Study
|
Controlled Clinical Trial to assess the effectiveness of topical application of C1 herbal oil on superficial external wounds and split thickness skin graft donor sites for surgical wound healing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maneesh Singhal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 5014C, 5th Floor, Teaching Block
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
Room 304, Third Floor
Jai Prakash Narayan Apex Trauma Centre
AIIMS, Raj Nagar
New Delhi
South
DELHI
110029
India |
| Phone |
26594430 |
| Fax |
|
| Email |
drmaneesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maneesh Singhal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 5014C, 5th Floor, Teaching Block
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
Room 304, Third Floor
Jai Prakash Narayan Apex Trauma Centre
AIIMS, Raj Nagar
New Delhi
South
DELHI
110029
India |
| Phone |
26594430 |
| Fax |
|
| Email |
drmaneesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maneesh Singhal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 5014C, 5th Floor, Teaching Block
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
Room 304, Third Floor
Jai Prakash Narayan Apex Trauma Centre
AIIMS, Raj Nagar
New Delhi
South
DELHI
110029
India |
| Phone |
26594430 |
| Fax |
|
| Email |
drmaneesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (CCRAS)
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 ( India )
Telephone : 91-011-28525862/28525897/28525852
Fax : 91-011-28520748/28525959 (Office of the DG) |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Ministry of AYUSH, Government of India
61-65, Institutional area, Opposite D Block, Janakpuri
New Delhi 110058 |
| 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 Maneesh Singhal |
Jai Prakash Narayan Apex Trauma Centre, AIIMS |
Department of Plastic, Reconstructive & Burns Surgery, Room 304, 3rd Floor
South
DELHI |
26594430
drmaneesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having Superficial external wounds and Split thickness skin graft (STSG) donor sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C1 Herbal Oil |
C1 herbal oil is applied topically over STSG donor site as a thin layer of dressing in gel form and assessed for healing over next 10 to 21 days. |
| Comparator Agent |
Paraffin guage |
Conventional dressing is applied on STSG donor site and assessed for healing over the next 10 to 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with wounds requiring STSG cover |
|
| ExclusionCriteria |
| Details |
1. Known allergy/hypersensitivity to any of the components of the dressing
2. Fracture/DVT of lower extremity
3. A skin disorder that is chronic or currently active
4. Polytrauma patients
5. Wound at the surgical site prior to surgery
6. Neurological deficit at wound site (Hemiplegia etc.)
7. Haemoglobin level < 7.0 g/dl
8. Serum Albumin <3 g/dl
9. Subjects who, in the opinion of investigator, may not complete the study for any reason
10. Hepatic failure, renal failure, coagulopathy, known cases of Diabetes mellitus
11. Immunocompromised patients such as with Acquired immunodeficiency syndrome or receiving systemic immune suppression
12. Patients who have psychiatric disorders or physical disabilities that hinders the study
13. Pregnancy or Lactation
14. Patient has history of poor wound healing, history of smoking/drug/alcohol abuse
15. Poor prognosis patients unlikely to survive the trial period
16. Patients where a reference wound cannot be treated in isolation from other wounds |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time to complete re-epithelisation
2. Incidence of Wound infection
3. Incidence of Adverse Reactions including allergic contact dermatitis |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dressing Adherence Score
2. Pain during dressing changes
3. Any systemic effects after treatment
Incidence of Blistering |
10 days
2 weeks
6 days |
|
|
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)
|
31/05/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a controlled, open label two phase clinical trial. Patients of age group between 18 and 60 years of either gender who present with superficial external wounds or raw areas requiring split thickness skin graft (STSG) coverage of at least 2 strips will be enrolled in the study. The study is being conducted at Jai Prakash Narayan Apex Trauma Centre, New Delhi, India. In first phase of the trial, C1 herbal oil will be used on STSG donor sites to assess the healing properties of the oil. The main ingredient of C1 herbal oil is an ayurvedic folklore medicine used for wounds and skin diseases, recommended for wound cleansing and healing purposes in ayurvedic classics. The physicochemical standards for use of this drug have been developed by the CCRAS.This clinical trial of herbal dressings in split thickness skin graft (STSG) donor sites is directed to find and validate the wound healing properties of herbal medicines, as claimed conventionally. if validated, it would go a long way in decreasing healthcare costs besides including herbal medicines in mainstream clinical medicine. |