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CTRI Number  CTRI/2024/08/072163 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Sadyo Vrana(Acute traumatic wound) by Ayurveda 
Scientific Title of Study   A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Nula Taila In The Management Of Sadyo Vrana. 
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 Rohan Pradipbhai Trivedi 
Designation  PG Scholar Shalya Tantra  
Affiliation  G. J. Patel Institute of Ayurvedic Studies and Research 
Address  DEPARTMENT OF SHALYA Tantra, OPD NO. 25, S. G. Patel Ayurvedic Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat-388120

Anand
GUJARAT
388120
India 
Phone  7990085302  
Fax    
Email  Rohan.trivedi783.rt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay L Trivedi 
Designation  PROFESSOR 
Affiliation  G. J. Patel Institute of Ayurvedic Studies and Research 
Address  DEPARTMENT OF SHALYA Tantra, OPD NO. 25, S. G. Patel Ayurvedic Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat-388120

Anand
GUJARAT
388120
India 
Phone  8128012211  
Fax    
Email  drsanjaytrivedi888@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay L Trivedi 
Designation  PROFESSOR 
Affiliation  G. J. Patel Institute of Ayurvedic Studies and Research 
Address  DEPARTMENT OF SHALYA Tantra, OPD NO. 25, S. G. Patel Ayurvedic Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat-388120

Anand
GUJARAT
388120
India 
Phone  8128012211  
Fax    
Email  drsanjaytrivedi888@gmail.com  
 
Source of Monetary or Material Support  
S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 
 
Primary Sponsor  
Name  Dr Rohan Pradipbhai Trivedi 
Address  Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388120 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NILL  NILL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohan Pradipbhai Trivedi  S. G. Patel Ayurveda Hospital and Maternity Home  OPD No. 25, Department of Shalya Tantra, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT 		 7990085302

Rohan.trivedi783.rt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL-HUMAN ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: SADYOVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-ropaNa-karma रोपण-कर्म (Procedure Reference: Sharangadhara Samhita, Procedure details: Local application of jatyadi taila prepared from jati patra, nimba patra, patola patra, naktamal patra, sikta, madhuka kushta, nisha katurohini, manjistha, padmak, lodhra, abhaya, neelam, utpala, tuttha, sariva, naktamal beeja, & tila taila.Dip gauze in jatyadi taila should be applied over the wound for 28 days.)
(1) Medicine Name: Triphala Guggulu , Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 28 Days
(2) Medicine Name: Gandhak Rasayan Vati, Reference: Yogaratnakar Rasayanadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 28 Days
(3) Medicine Name: Rasayan Vati, Reference: Yogaratnakar Rasayanadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 175(mg), Frequency: tds, Duration: 28 Days
2Intervention ArmProcedure-ropaNa-karma रोपण-कर्म (Procedure Reference: Vangasen Samhita, Procedure details: Local application of nula taila prepared from apamarga moola, bala moola, & tila taila. Dip gauze in nula taila and apply it over the wound for 28 days.)
(1) Medicine Name: Triphala Guggulu , Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 28 Days
(2) Medicine Name: Gandhak Rasayan Vati, Reference: Yogaratnakar Rasayanadhikar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 28 Days
(3) Medicine Name: Rasayan Vati, Reference: Yogaratnakar Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 175(mg), Frequency: tds, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Traumatic CLW (Contused Laceration Wound)
2. Abrasion Wound
3. Lacerated Wound
4. Chronicity is less than 7 days.
5. Irrespective of age, gender, religion, occupation, & economic status. 
 
ExclusionCriteria 
Details  1. Chronic non-healing wounds like tubercular wounds, leprotic wounds, malignant wounds, diabetic wounds, burns, Wounds having excessive loss of tissues, fistula in Ano, etc.
2. Age: Below 18 and Above 60
3. Chronicity of more than 7 days.
4. another traumatic wound like a crush injury, penetrating, blunt.
5. Pregnant & Lactating women
6. Any Comorbid condition
7. Diagnosed cases of HIV and HbsAg
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Nula Taila will have an impact on early epithelization in Sadyo Vrana.   7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Nula Taila will have an impact on the complete healing of the Sadyo Vrana.  28 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 3/ Phase 4 
Date of First Enrollment (India)   10/10/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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   Study to see the efficacy of Nula Taila on 15 patients compared with Jatyadi Taila on the rest 15 Patients suffering from Sadyo Vrana. A patient will be advised to apply the dipped gauge of oil to the wound site once a day for 28 days or up to healing, whichever is less. a patient will be advised to take Triphala Guggulu 2 tab. Bid after food with warm water, Gandhak rasayan 2 tabs. Bid after food with warm water, Rasayan Vati 1 tab. Tid after food with warm water During the study, a total of 30 patients will be enrolled for 28 days with 5 follow-ups (0, 7, 14, 21, 28 Days, and 1 month after completion of the treatment). Need for study- To Assess the vranaropan action of Nula Taila in Sadyo Vrana. 
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