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CTRI Number  CTRI/2020/03/024004 [Registered on: 16/03/2020] Trial Registered Prospectively
Last Modified On: 12/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Vidangadi guggulu and Chandanadi tail in wound patients 
Scientific Title of Study   A Clinical study on Vidangadi Guggulu and Chandanadi taila in the management of vrana  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tripti Netam 
Designation  PG scholar 
Affiliation  Shree Narayan Prasad Awasthi government ayurved college raipur chhattisgarh  
Address  Dept of Shalya tantra Shree Narayan Prasad Awasthi government ayurved college raipur chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  6263314036  
Fax    
Email  triptinetam92@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uttam kumar Nirmalkar 
Designation  lecturer 
Affiliation  Shree Narayan Prasad Awasthi government ayurved college raipur chhattisgarh  
Address  Dept of Shalya tantra Shree Narayan Prasad Awasthi government ayurved college raipur chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  8234057199  
Fax    
Email  druk01508@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balendra singh 
Designation  reader 
Affiliation  Shree Narayan Prasad Awasthi government ayurved college raipur chhattisgarh  
Address  Dept of Shalya tantra Shree Narayan Prasad Awasthi government ayurved college raipur chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  9039180335  
Fax    
Email  drbalendrasingh@gmail.com  
 
Source of Monetary or Material Support  
Dept of Shalya tantra Shri N P A Govt Ayurvedic College Raipur Chhattisgarh 
 
Primary Sponsor  
Name  Shree Narayan Prasad Awasthi Govt Ayurved College Raipur Chhattisgarh 
Address  Shree Narayan Prasad Awasthi Govt Ayurved college Raipur Chhattisgarh 
Type of Sponsor  Other [Shree Narayan Prasad Awasthi Govt Ayurved College Raipur Chhattisgarh] 
 
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 
TRIPTI NETAM  Shri Khudadad Doonga ji Govt Ayurved Hospital Raipur  OPD NO 15 Dept of Shalya tantra Shri Khudadad Doonga ji Govt Ayurved Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
6263314036

triptinetam92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T149||Unspecified injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Triphala guggulu and jatyadi tail  Dose of triphala guggulu- 1gm twice in a day Route of administration - orally Route of administration of jatyadi tail -locally Duration of therapy will be of 1 month 
Intervention  Vidangadi guggulu and Chandanadi tail  Dose of Vidangadi guggulu -1gm twice in a day Route of administration- orally Route of administration of Chandanadi tail -locally Duration of therapy will be of 1 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age between 18 – 60 years irrespective of gender, prakriti, religion etc .
Patient having classical feature of vrana.
Vrana within size of 7×7cm2 or less
Vrana in Diabetic patient with control sugar level.
Dusta vrana with proper blood circulation and sensation.
Postoperative wound w.s.r. to anal canal surgery.
 
 
ExclusionCriteria 
Details  1. Patient below age of 18 and more than 60yrs.
2. Patient is not willing to participate in the trial.
3. Patient with disorder like leprotic ulcer, Tubercular ulcer, osteomylitis
4. Patient with HIV , HBsAg, VDRL positive.
5. Infected malignant ulcer , ischemic ulcer, gangrene.
6. Patient having known allergy to trial drug.
7. Vrana in visceral ,bony , spinal injuries.
8. Pregnancy.
9. Burn cases
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To increase healing process of wound and prevent from microbial agent   1 month 
 
Secondary Outcome  
Outcome  TimePoints 
To improve quality of life   1 month 
 
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 1/ Phase 2 
Date of First Enrollment (India)   20/03/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

    Ayurveda is a science of life and it is time tested health system with vast scope of trials to prove certain principle as well as therapeutic effect of the medicine. Ever since the life originated human being has been susceptible to injury. Vrana is first medical problem faced by human being. Ayurveda has given much importance to management of vrana, In modern era there is remarkable increase in the number of traumatic cases due to mechanical vehicle, traffic major population, rapid industrialization.

    The word vrana derived from gatravichurnne, means destruction of tissue,.A pathology in which there is destruction of tissue and formation of scar after healing that remain for a longtime is called as vrana. Vrana vastu or vranaadhisthan are mainly on the basis of involvement of body structure which are categorised mainly under eight sight, twaka( skin), mamsa( muscle), sira( vessels), snayu( ligament), Asthi( bones), sandhi( joints), koshta (abdominal and thoracic viscera) and marma (some vital parts of body). Vrana is the condition associated with Dhatu nasha (destruction of tissue ), and characterized by Vedana (pain), Srava (discharge), and  vikriti ( deformity).

    Acharya Sushrut  classified vrana in two categories as Nija and Agantuj causes. Nija is a term used for vrana which is caused due to instrinsic factors whereas Agantuj vrana is due to external factors like burns, trauma, accidents , animal bites etc.

              Wound healing by 2 process primary intension and secondary intention, which starts immediately after injury but factor like microbial infection, slough, foreign body affect normal healing process and delayed  healing may result of  loss of function of affected part.5 In modern science antibiotic and antiseptic treatment may be used with the aim of preventing or treating such patients. In ayurveda classics particularly SUSHRUT SAMHITA mentioned 60 upakramas in the management of vrana to achieve good approximation, early healing, without complication and acceptable scar, Taila is one amonge these upakrama, where he mentioned both shodhan and ropana effect. There have been many studies on taila, ghrita, pichu, vranaprakshalan, dhupan,etc .CHANDANADI TAILA  is proved to be effective in vranaropanam according to SUSHRUT SAMHITA and VIDANGADI GUGGULU, which is effective in preventing infection and enhancing wound healing property according to CHAKRADUTTA. So there is need to evaluate the effect of Chandanadi  taila and Vidangadi guggulu in vranaropan and vranashodhan.

 

 
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