FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096709 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study to Check if Sakriyam Oil is Safe for Healing Cuts 
Scientific Title of Study   An Open-Label, Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of Sakriyam Oil in the Management of Open Wound Injuries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CTSRS/2522 Version No 1.0 Dated 15 Sep 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranjitha S 
Designation  Principal Investigator 
Affiliation  RVS Ayurvedic Medical College Hospital and Research Centre 
Address  Ground Floor R.No-1, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road,

Bangalore
KARNATAKA
560091
India 
Phone  9972850853  
Fax    
Email  ranjushreshta10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sathyavathi LM 
Designation  HOD-Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  09739001749  
Fax    
Email  satyalm@samahitha.com  
 
Details of Contact Person
Public Query  
Name  Ms Arpita Malgi 
Designation  Team Lead - Clinical Operations 
Affiliation  Samahitha Research Solutions 
Address  Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore

Bangalore
KARNATAKA
560069
India 
Phone  06364898825  
Fax    
Email  arpita@samahitha.com  
 
Source of Monetary or Material Support  
GHK Pharmaceuticals Pvt. Ltd. FH02/402, GTM Forest & Hills, Opp.IIP, Mohkampur Khurd, Dehradun, Uttarakhand - 248005 
 
Primary Sponsor  
Name  GHK Pharmaceuticals Pvt. Ltd. 
Address  FH02/402, GTM Forest & Hills, Opp.IIP, Mohkampur Khurd, Dehradun, Uttarakhand - 248005 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ranjitha S  RVS Ayurvedic Medical College, Hospital and Research Centre  Room Number-1 Ground Floor, Srigandhadakavalu, Vishwaneedam Post, Outer Ring Road, Bangalore
Bangalore
KARNATAKA 		 9972850853

ranjushreshta10@gmail.com 
 
Details of Ethics Committee  
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T14||Injury of unspecified body region. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Sakriyam Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 6(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -Sakriyam Oil, applied topically to cover the wound area once or twice daily for up to 15 days, or until complete epithelialization, whichever occurs first.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female adults between 18 and 65 years of age.
2. Having mild-to-moderate open wound(s) less than 72 hours old at the time of screening.
3. Able and willing to provide written informed consent.
4. Women of childbearing potential must be willing to practice an acceptable method of contraception for the duration of the study.
5. Willingness and ability to comply with all study procedures, visit schedules, and follow-up assessments. 
 
ExclusionCriteria 
Details  1. Pregnant, breastfeeding, or planning pregnancy during the study.
2. Deep or complicated wounds with exposed bone or muscle.
3. Presence of diabetic ulcers, infected wounds, or gangrenous tissue.
4. Participation in any other interventional clinical trial within the past 30 days.
5. Known hypersensitivity or allergy to any constituent of Sakriyam Oil.
6. Any significant concurrent illness or condition that, in the opinion of the Investigator, may interfere with study participation, safety, or data interpretation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Absolute and percentage change in wound length (cm) from Baseline to Day 7 and Day 15.
2. Absolute and percentage change in wound width (cm) from Baseline to Day 7 and Day 15.
3. High-definition (HD) imaging–based assessment of wound healing at Day 15 compared to Baseline, documenting epithelialization and granulation tissue formation. 		 Screening & Baseline (Day 0),
Follow-up (Day 7 ±2),
End of Study (Day 15 ±2) 
 
Secondary Outcome  
Outcome  TimePoints 
hange in Subject Global Assessment (SGA) scores for redness, pus formation, swelling, pain, and itching from baseline to Day 7 and Day 15.

Change in Visual Analogue Scale (VAS) scores for pain and itching from baseline to Day 7 and Day 15.

Change in health-related quality of life scores as measured by the EQ-5D-5L questionnaire from baseline to Day 15.

Safety and tolerability endpoints, including:

Incidence and severity of adverse events.

Local tolerability outcomes such as erythema, dermatitis, or signs of infection.

Any serious adverse events recorded throughout the study period. 		 Screening & Baseline (Day 0),
Follow-up (Day 7 ±2), End of Study (Day 15 ±2) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/11/2025 
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="0"
Days="15" 
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  

This study is designed to evaluate Sakriyam Oil, a proprietary Ayurvedic topical formulation, in adults aged 18 to 65 years with mild-to-moderate open wounds less than 72 hours old. Wound healing is a complex process, and disruptions can lead to delayed recovery, infection, pain, and reduced quality of life. Although standard wound care exists, there is a need for safe, effective, and symptom-relieving topical alternatives.

The purpose of this study is to assess the safety and efficacy of Sakriyam Oil in promoting wound healing. The study will measure changes in wound size (length and width), monitor healing progression through high-definition imaging, evaluate symptom improvement (redness, swelling, pain, itching, and pus formation) using patient-reported tools such as the Subject Global Assessment (SGA) and Visual Analogue Scale (VAS), and assess health-related quality of life using the EQ-5D-5L questionnaire.

The study aims to generate structured clinical evidence on the therapeutic benefits and tolerability of Sakriyam Oil, supporting its potential use as a safe and effective topical treatment for mild-to-moderate open wounds.

 
Close