| CTRI Number |
CTRI/2022/07/044006 [Registered on: 14/07/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulation in the treatment of wound healing. |
|
Scientific Title of Study
|
Comparitive study to evaluate the efficacy of Prushnaparni siddha ghrut and Yashtimadhu tiladi ghrut local application in management of Shuddha Vrana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Piyush Yugalkishor Sharma |
| Designation |
MS Scholar Shalyatantra (Ayurveda) |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyala |
| Address |
Opd no 3 Department of Shalya Tantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar, Pune Department of
Shalyatantra, MAMs Sumatibhai Shah Ayurved College Hadapsar Pune
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9158904441 |
| Fax |
|
| Email |
piyukhudana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamalakar V Gajare |
| Designation |
MS Phd Associate Professor ShalyaTantra |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyala |
| Address |
Opd no 3 Department of Shalya Tantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar, Pune Department of
Shalyatantra, MAMs Sumatibhai Shah Ayurved College Hadapsar Pune
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9822071732 |
| Fax |
|
| Email |
drgajarekv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamalakar V Gajare |
| Designation |
MS Phd Associate Professor ShalyaTantra |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyala |
| Address |
Opd no 3 Department of Shalya Tantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar, Pune Department of
Shalyatantra, MAMs Sumatibhai Shah Ayurved College Hadapsar Pune
MAMs Sumatibhai Shah Ayurved College Hadapsar Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9822071732 |
| Fax |
|
| Email |
drgajarekv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ShalyaTantra Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi road Hadapsar Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vd Piyush Y Sharma |
Sane Guruji Arogya Kendra |
Opd number 3, Department of Shalya Tantra, Sane Guruji Arogya Kendra Malwadi road Hadapsar Pune
Pune
MAHARASHTRA |
9158904441
piyukhudana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T07||Unspecified multiple injuries. Ayurveda Condition: SUDDHAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Tiladi Ghrut, Reference: Sushrut Samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prushnaparni siddha Ghrut, Reference: Sushrut Samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-Patient having Healthy wound.
2-Age 18 to 60 yrs., Irrespective of Gender.
3-Subcutaneous wound size 1 × 1 cm to 15 × 15cm.
4-Diabetic Mellitus. |
|
| ExclusionCriteria |
| Details |
1-Gangrenous wound
2-Neo-plastic ulcer
3-Burn, Arterial ulcer
4-Bed Sores
5-Varicose ulcer
6-HIV & Immuno-compromised patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Prushnaparni siddha Ghrut in management of Shuddha Vrana |
Total duration of study will be 18 months
Follow up will be taken on 1st day 5th day 10th day and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To observe the duration required for the complete healing i.e. Rudh Vrana
2. To study the rate of healing in Shuddha Vrana
3. To see the adverse effect of Prushnaparni Siddha Ghrut |
Total duration of study will be 18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/07/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Shuddha Vrana is more faced condition. Once Vrana become Dushta it worsens the condition of the patient which delays healing process of Vrana, different complications and may become fatal. Wound healing is a natural process. Wound healing depends upon many factors like slough, infection and foreign body which affect the normal process of healing. In present day wound is said to be healed when epithelialization is complete, but Acharya Sushruta has given much emphasis on Vaikrutapaham. Infected wound takes more time to heal than a healthy wound in a normal body which heals early & minimal scar. Wound healing is mechanism whereby the body attempts to restore the integrity of injured part. Hence good wound healing with minimal scar formation is the prime moto. Prushnaparni siddha ghrita Is Vranropak because of its RASA-VIRYA-VIPAK-GUNN (LAGHU,SNIGDH,SAR) and Yashtimadhu Tiladi ghrita is Vrana Ropak ,use of such plant material in the management of wound when there is unavailability of solutions will help these issues resolved.
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