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CTRI Number  CTRI/2020/04/024658 [Registered on: 15/04/2020] Trial Registered Prospectively
Last Modified On: 08/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Assesment safety and efficacy of Ayurvedic Formulation AYUSH AGT in external wounds. 
Scientific Title of Study   An open label Clinical trial to evaluate clinical efficacy and safety of Ayush AGT for external wounds.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Savita poshatti Gopod 
Designation  Research officer(Ayu) 
Affiliation  central council for research in ayurvedic sciences 
Address  Regional Ayurveda research institute for skin disorders, New Rajeev nagar, Technical section, Room no. 205, Payakapuram, Vijayawada

Krishna
ANDHRA PRADESH
520015
India 
Phone  9177777631  
Fax    
Email  savitagopod18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Savita Gopod 
Designation  Research officer(Ayu) 
Affiliation  Central council for Research in Ayurvedic sciences, 
Address  Regional ayurveda research institute for skin disorders, New Rajeev nagar, Payakapuram 520015

Krishna
ANDHRA PRADESH
520015
India 
Phone  9177777631  
Fax    
Email  savitagopod18@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Savita Gopod 
Designation  Research officer(Ayu) 
Affiliation  Central council for research in ayurvedic sciences 
Address  Regional ayurveda research institute for skin disorders , New Rajeev nagar, payakapuram Vijayawada

Krishna
ANDHRA PRADESH
520015
India 
Phone  9177777631  
Fax    
Email  savitagopod18@gmail.com  
 
Source of Monetary or Material Support  
Central council for Research in Ayurvedic Sciences 
 
Primary Sponsor  
Name  Central council for Research in Ayurvedic Sciences 
Address  Jawaharlal neharu, bharatiya chikista evam homeopathy anusandhan bhavan, 61-65 institutional area, opp D Block, Janakapuri, New Delhi 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrHemant Panigraha  Central Ayurveda Research Institute for Cardiovascular Diseases  Rd Number 66, Punjabi Bagh Enclave, Swayamsidha Colony, Punjabi Bagh, Delhi, 110026 Out patient department
South West
DELHI 		 8368351010

drhemanta71@gmail.com 
DrAnil Avahad  Regional Ayurveda Research Institute for Skin Disorders, Ahmedabad (RARISD)  over bridge, Block A & D, second floor, Bahumali bhavan, Manjushree mill compound, Girdharnagar, Asarwa, Out p[atient department
Ahmadabad
GUJARAT 		 9510176085

dranil.avhad@gov.in 
Dr Savita gOpod  Regional Ayurveda Research Institute for Skin Disorders, New Rajeev Nagar, Payakapuram,  RARISD, New Rajeev Nagar,Payakapuram, Out patient department
Krishna
ANDHRA PRADESH 		 9177777631

savitagopod18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional ethics committee, Ahmadabad  Approved 
Institutional ethics committee, Punjabi bagh, New Delhi  Approved 
Institutional Ethics committee, Vijayawada  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , , (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayush AGT cream for External application on wound  Dose -Quantity Sufficient Dosage form -Gel based ointment Route of Administration -Topical Time of Administration - Applied on wound bed once a day and bandaged with the sterile material. Packing for- 15 gm ointment (15 gmx4 tubes) Duration of therapy - 4 weeks  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  .1 Patients of either sex with age between 18 and 60 years

2 Patients with Superficial externalwounds requiring dressing


3. Solitary wound not less than 1 inches (2.5 cm) in diameter

4 Patienwilling to participate in the study for 1 month
 
 
ExclusionCriteria 
Details  1Known allergy/hypersensitivity to any of the components of the dressing
2.Wound associated with fracture

3.Wound associated with skin disorder that is chronic or currently active like psoriasis, eczema

4.Neurological deficit at wound site

5.Hemoglobin level <7.0 g/dl, serumalbumin <3 g/dl

6.Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S.Creatinine > 1.2 mg/dl)

7.Known cases of Diabetes Mellitus, AIDS & other sexually
transmitted diseases, Malignancy or known history of coagulopathy

8.Patients receiving immune-suppressive medication

9. Pregnancy or lactation

10.Varicose veins/Deep Vein Thrombosis

11.Wounds requiring full thickness graft
12.Patients where a reference wound cannot be treated in isolation fromother wounds.

13.H/o hypersensitivity to any of thetrial drugs or their ingredients.

14.Patient taking participationin any other clinical trial

15.Any other condition which the Investigatorthinksmay jeopardize the study.



 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome Measures
Time to complete re-epithelialization (Time Frame: 4 weeks.)  		 Primary Outcome Measures
Time to complete re-epithelialization (Time Frame: 4 weeks.)  
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of wound infection (Time Frame: 4 weeks
2.Pain during dressing changes (score) [Time Frame: 2 weeks]
3.Any systemic effect after treatment CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes.
4.Incidence of Blistering [Time Frame: 0-6 days]
5.Incidence of adverse reactions  		 7th, 14th, 21 stand 28th 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/ Phase 3 
Date of First Enrollment (India)
Modification(s)  		 10/06/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a An Open Label Clinical Trial to Evaluate Clinical Efficacy and Safety of AYUSH AGT cream for External Wounds. Sufficient quantity of AYUSH AGT cream will apply on open wound for four weeks. Study sample size will be 30 patients. It will be conducted in three centers in India. Primary Outcome Measures is to study time frame required time to complete re-epithelialization and to assess Percentage area of re-epithelialization on day 7, 14, 21and 28 via Bates-Jenson wound assessment tool. Secondary outcome measures to see the Incidence of wound infection while applying AYUSH AGT cream, Pain during dressing changes (score) any systemic effect after treatment CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes, Incidence of Blisterin and to observe incidence Incidence of adverse reactions during treatment 
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