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CTRI Number  CTRI/2024/10/075034 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Jaloukavacharana in non healing ulcer 
Scientific Title of Study   Clinical evaluation of Jaloukavacharana in Dushta Vrana(Non-Healing Ulcer) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M M Abdul Shukkoor 
Designation  Professor and HOD 
Affiliation  Govt Ayurveda College Hospital Tripiunithura 
Address  Professor and HOD Salyatantra Department Govt Ayurveda College Hospital Tripiunithura , Ernakulam 682301

Ernakulam
KERALA
682301
India 
Phone  9447661001  
Fax    
Email  drsukoor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M M Abdul Shukkoor 
Designation  Professor and HOD 
Affiliation  Govt Ayurveda College Hospital Tripiunithura 
Address  Professor and HOD Salyatantra Department Govt Ayurveda College Hospital Tripiunithura , Ernakulam 682301

Ernakulam
KERALA
682301
India 
Phone  9447661001  
Fax    
Email  drsukoor@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M M Abdul Shukkoor 
Designation  Professor and HOD 
Affiliation  Govt Ayurveda College Hospital Tripiunithura 
Address  Professor and HOD Salyatantra Department Govt Ayurveda College Hospital Tripiunithura , Ernakulam 682301

Ernakulam
KERALA
682301
India 
Phone  9447661001  
Fax    
Email  drsukoor@gmail.com  
 
Source of Monetary or Material Support  
Government of India, Ministry of Ayush, Research and Innovation in AYUSH under Ayurgyan Scheme B- Block, GPO Complex AYUSH Bhawan,INA Market New Delhi-110023  
 
Primary Sponsor  
Name  CCRAS 
Address  Government of India Ministry of Ayush Reasearch & Innovation in AYUSH under Ayurgyan Scheme B- Block, GPO Complex AYUSH Bhavan, INA Market New Delhi - 110023 
Type of Sponsor  Government funding agency 
 
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 M M Abdul Shukkoor  Govt Ayurveda College Hospital, Tripunithura  Govt Ayurveda College, Salyatantra Department, Thripunithura, Kochi, Kerala- 682301
Ernakulam
KERALA 		 9447661001

drsukoor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Govt. Ayurveda College, Tripunithura, Kochi,Kerala-682301  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bandhanakarma बtनकम (Procedure Reference: Reprint ed. Varanasi: Chaukhambha orientalia; 2009. Sushruta Chikitsa Sthan 1/8; Sushruta Samhita, Nibandha sangraha, Yadavji Trikamji; p. 397. , Procedure details: 1. Punarnavadi Kashaya 90ml BD at 6am & 6pm orally for 28 days. II. Kshalana with Triphala Kashaya with Sufficient quantity as external application for 28 days. III. Jathyadi Tailam quantity sufficient as external application for 28 days. Sample size – 228 ( 114 in group A, intervention arm & Group B, comparator arm ) )
2Intervention ArmProcedure-jalaukAvacaraNam जलौकावचरणम् (Procedure Reference: Surutha;Susruthasamhitha with nibandhasangraha commentary of Sri Dalhanacharya, Edited by Vaidya Jadvji Trikamji Acharya and Narayan Ram Acharya Kavyatirtha , Chaukamba Sanskrit sansthan -2013;Sutra sthana chapter 13, Procedure details: 1. Punarnavadi Kashaya, 90ml BD at 6am & 6pm orally for 28 days. II. Kshalana with Triphala kashaya with Sufficient quantity as external application for 28 days. III. Jathyadi Tailam quantity sufficient as external application for 28 days. 1V. Jaloukavacharana on every 3days, total 10 sittings )
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Venous ulcer
• Arterial ulcer
• Diabetic foot ulcer
• Subjects within the age group 20-70
• Wound size of 10x10 CM area
 
 
ExclusionCriteria 
Details  • Tuberculosis
• Malignancy
• Burns
• Gangrene
• Traumatic ulcer (within 7 days)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Healing effect of Jaloukavacharana in Non healing ulcer assessed through ulcer area measurement using digital planimetry.
2.The effect in improvement of circulation in Non healing ulcer by Jaloukavacharana, will be assessed through Transcutaneous oxygen tension measurement.
3. Healing effect of Jaloukavacharana in Non healing ulcer, will be assessed through Pressure Ulcer Scale for Healing.
 		 Assessment will be done on 0th day, 3rd day, 6th day, 9th day, 12th day, 15th day, 18th day, 21st day, 24th day, 27th day and 28th day. The study period is 28 days and follow up period is 160 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement of circulation in Non healing ulcer affected area by Jaloukavacharana assessed through Transcutaneous oxygen tension measurement
2.Healing effect of Jaloukavacharana in Non healing ulcer assessed through Pressure Ulcer Scale for Healing

 		 Assessed in 3 days interval 
 
Target Sample Size   Total Sample Size="228"
Sample Size from India="228" 
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 3 
Date of First Enrollment (India)   15/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The aim of the study is to assess the healing effect of Jaloukavacharana in non healing ulcer. The study has three objectives. The objective is to assess the healing effect of Jaloukavacharana in Non Healing Ulcer by using Digital Planimetry, Transcutaneous oxygen tension measurement and PUSH Score.

        The study participants diagnosed with Non Healing Ulcer will be admitted in Govt.Ayurveda College Hospital Tripunithura for conduct of trial. The patients will be grouped into two A and B. Both groups will have cleaning and dressing, internal medication. Cleaning of the wound will be done with triphala kashaya and dressing will be done with Jathyadi taila daily upto 21days. Internally punarnavadi kashaya will be given for 21 days in Non Healing Ulcer patients. In addition to above treatment Group A will have Jaloukavacharana on every 3rd day upto 21 days, total 8 sittings. The Symptoms and signs are recorded by following standard method and both groups are compared and results will be statistically analysed.

 
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