| CTRI Number |
CTRI/2024/11/076682 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Ayurvedic formulation Chandanadi yamakam as compare to Allopathic formulation Silver sulfadiazine in treatment of 1st and 2nd degree burn |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study of efficacy of Chandanadi Yamakam in the management of Dagdha Vrana w.s.r. to 1st and 2nd Degree Burns. |
| 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 RANJIT SWAPAN SARDAR |
| Designation |
MS SHALYA TANTRA SCHOLAR ( AYURVEDA ) |
| Affiliation |
Dr. VJD Gramin Ayurved Mahavidyalaya, Patur, Akola |
| Address |
Dr. VJD Gramin Ayurved Mahavidyalaya, Near Renuka-mata Mandir, Patur, Tah-Patur, Dist-Akola, Pin-444501
Akola MAHARASHTRA 444501 India |
| Phone |
8007183035 |
| Fax |
|
| Email |
sardarranjit1994@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR. JAGRUTI RODE |
| Designation |
Assi. Professor |
| Affiliation |
Dr. VJD Gramin Ayurved Mahavidyalaya, Patur, Akola |
| Address |
Department of Shalyatantra
OPD No. 16
Dr. VJD Gramin Ayurved Mahavidyalaya, Near Renuka-mata Mandir, Patur, Tah-Patur, Dist-Akola, Pin-444501
Akola MAHARASHTRA 445401 India |
| Phone |
7972669183 |
| Fax |
|
| Email |
drjagrutiambekar50@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR JAGRUTI RODE |
| Designation |
Assi. Professor |
| Affiliation |
Dr. VJD Gramin Ayurved Mahavidyalaya, Patur, Akola |
| Address |
Department of Shalyatantra
OPD No. 16
Dr. VJD Gramin Ayurved Mahavidyalaya, Near Renuka-mata Mandir, Patur, Tah-Patur, Dist-Akola, Pin-444501
Akola MAHARASHTRA 445401 India |
| Phone |
7972669183 |
| Fax |
|
| Email |
drjagrutiambekar50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya tantra, Dr. VJD Gramin Ayurved Mahavidyalaya, Patur, Dist- Akola, Maharashtra, India 444501 |
|
|
Primary Sponsor
|
| Name |
Dr. VJD Gramin Ayurved Mahavidyalaya |
| Address |
Near Renuka mata mandir, Patur Tah-Patur Dist-Akola, Maharashtra, 444501 |
| 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 |
| Dr Ranjit Swapan Sardar |
Dr. VJD Gramin Ayurved Mahavidyalaya |
OPD NO. 18, Department of Shalyatantra, Dr. VJD Gramin Ayurved Mahavidyalaya, near Renuka mata mandir, Patur, Tah-Patur, Dist-Akola, Maharashtra Akola MAHARASHTRA |
8007183035
sardarranjit1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr VJD Gramin ayurved mahavidyalaya Patur Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T310||Burns involving less than 10% of body surface. Ayurveda Condition: DAGDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandanadi Yamakam, Reference: Charadatta Samhita , Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Silver sulfadiazine | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Wound of 1st and 2nd degree burns.
2) Burn wound size upto 10cm × 10cm
3) Patients having age between 18-60 years will be included.
4) Patients will be selected irrespective of sex, marital status, religion, educational and economical status.
5) Burn over extremities, abdomen, chest and back only.
6) Patients with well controlled diabetes mellitus.
7) Co-operative patients and ready to give written consent. |
|
| ExclusionCriteria |
| Details |
1) Wound of 3rd and 4th degree burns.
2) Burn wound size above 10cm × 10cm
3) Patients having age below 18 & above 60 years.
4) Patients not willing to participate in the study.
5) Burn wound of TB, Leprosy, HIV +ve, HbSAg + ve, Toxemia, Shock.
6) Moist heat, Electric burns, Chemical burns, Radiation and cold burns.
7) Chronic and Gangrenous would.
8) Non co-operative Patient.
9) Patients with uncontrolled diabetes mellitus.
10) Suicidal burns ( Medico Legal Cases ). |
|
|
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 |
Symptoms of burn wound like
Burning pain, Discoloration of skin, Blister formation, wound formation, serous secretion
Will be decreased and control over burn wound with reference to Dagdha vrana. |
0th, 3rd, 5th, 10th, 15th and 21st Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of burn & wound healing up giving the cosmetic effect. |
5 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Burns are global public health problem, accounting for estimated death 1,80,000 annually and the estimate burn incidence in India is approximately 6-7 million. Burn injury has been associated with the evolution of human civilization since time immemorial. Burn injuries has always been faced by human in different era with change of mode of injury from past to present. Unlike other diseases the basics of burn injury remains more or less same.
In Ayurveda, burn injury has been described in the name of “Dagdha Vranaâ€. The concept of Dagdha vrana was found in different treatises. In Sushruta Samhita details regarding Classification, Clinical features and detailed management according to types are described. The basic concepts and principle of management of burn injury is described in Ayurveda are very much relevant and useful in this era of modern surgery. Sushrut Samhita, the treasure of surgical knowledge of ancient Indian Civilization, is a rich source of information regarding burn injury, assessment and management.
Ayurveda is an applied science and a time-tested health system with a wide range of experiment. The goal of increasing the acceptance of Ayurveda on a world wide is to prove certain theories and the therapeutic effects of the medicines. All Brihatrayee and Laghutrayee and other relevant text book of ayurveda studied to search the different data regarding the Dagdha Vrana (Burn Injury). The collected data evaluated scientifically to make it usable in the modern era of surgery. The result show that although there is change in mode of burn injury found in modern era, the basic principles of etiology, classification, management and use of dressing material are almost the same as standard burn wound management of contemporary medical science. So the benefits of ayurveda can be introduced in modern era of burn care.
In modern science there is standard contemporary management are available, but this methods and material failed to give good cosmetic effect. It has always been a process to look for a better solution in order to get past the limitation that have existed in the past the past. This is why researches are still looking for a medicinier pharmacological combination that can meet the ideal criteria.
Always the altimate aim of any surgeon is creating the favourable conditions which allow the wound to heal properly. Because exposure to infection and prolong inflammatory phase delay the healing process of the wound. The shalya chikitsak makes it very clear that the vrana ( wound) is most important for the success of surgeon.
According to modern science classification of burns. Types of buns 1) Thermal injury A) Scald B) Flame burn C) Flash burn D) Contact burn 2) Electric injury 3) Chemical injury 4) Cold Injury 5) Ionising radiation 6) Sun burn
Classification of burns depending on thickness of skin involved.
1) 1st degree burn :- Here the epidermis look red and painful, No blisters, heal rapidly in 5-7 days by epithelialization with supportive medicine. It shows capillary filling.
2) 2nd degree burns :- The affected area is mottled, red, painful with blisters, heals by epithelisation in 14-21 days by using supportive medicine. Superficial 2nd degree burn heals causing pigmentation. Deep 2nd degree burn heals causing scaring and pigmentation, sensation present but no blanching.
3) 3rd degree burns :- The affected area is charred, parchment like painless and insensitive, with thrombosis of superficial vessels.It requires grafting. Charred, denatured, insensitive, contracted full thickness burn is called as eschar. These wound must heal by re-epithelisation from wound edge.
4) 4th degree burns :- Involves the underlying tissues muscles and bones.
In sushruta samhita, burn wound and it’s management described (i.e. dagdha vrana) is in the sutra-sthana adhyaya no.12 ( Agnikarma-vidhi adhyaya ).
In this adhyaya 4 types of burns described 1) Plushta dagdha 2) Durdagdha 3) Samyagdagdha 4) Atidagdha
According to modern science we can correlate Plushta-dagdha and Durdagdha with 1st degree and 2nd degree burn, as the sign and symptoms of this are same.
Chandanadi yamakam is described in ’Chakradatta’ and ’Yogaratnakara’, where mentioned that the above composition is useful in all types of Dagdha vrana. Therefore this is my humble attempt to research the mechanism of action of Chandanadi yamakam, which could be beneficial in the future and could be free of any side effects, have good efficacy and provide better cosmetic effect.
Ayurveda is the name of the conventional, age-old Indian system of health sciences. This useful procedure’s skills was passed down from one generation to the next, curing people of a range of severe illnesses and demonstrating its value to society. Your lifestyle refers to the behaviors and activities that make up your daily existence. |