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
|
|
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
|
|
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. |