| CTRI Number |
CTRI/2022/06/043415 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
21/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Role of Manjishtadi Vikeshika in the management of Agni Dagdha vrana - A clinical study with special reference to 1st and 2nd degree burns. |
|
Scientific Title of Study
|
A Randomized open labelled controlled clinical study to evaluate the effect of Manjishtadi vikeshika in the management of Agni Dagdha vrana with special reference to 1st and 2nd degree burns. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumukhi R |
| Designation |
Second year PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room number 207,
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura post, Bangalore.
Room number 207,
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura post, Bangalore.
Bangalore
KARNATAKA
560082
India |
| Phone |
9632733090 |
| Fax |
|
| Email |
sumukhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padma |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room number 207,
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura post, Bangalore.
Room number 207,
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura post, Bangalore.
Bangalore
KARNATAKA
560082
India |
| Phone |
9900410580 |
| Fax |
|
| Email |
Drpadmabhats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumukhi R |
| Designation |
Second year PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room number 207,
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura post, Bangalore.
Room number 207,
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura post, Bangalore.
Bangalore
KARNATAKA
560082
India |
| Phone |
9632733090 |
| Fax |
|
| Email |
sumukhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Sumukhi R |
| Address |
Room number 207,
Department of PG studies in Shalya Tantra,
Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura road, Udayapura post, Bangalore. |
| Type of Sponsor |
Other [Self] |
|
|
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 Sumukhi R |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of PG studies in Shalya Tantra, 21 st KM, Kanakapura road, Udayapura post, Bangalore.
Bangalore
KARNATAKA |
9632733090
sumukhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T312||Burns involving 20-29% of body surface. Ayurveda Condition: DAGDHA VRANA, BURN WOUND, (2) ICD-10 Condition:T312||Burns involving 20-29% of body surface. Ayurveda Condition: burn wounds, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Paraffin gauze | Paraffin gauze is extensively utilized as a dressing material in burn wounds. It allows for easy and painless dressing changes, maintains adequate moisture, promotes exude drainage, and is cost effective, but it does not aid in the prevention of post-burn complications. Apart from these features, it does not hold any medicinal property to promote wound healing. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi taila, Reference: Bhaishajya Ratnavali, Sadhyovrana chikitsa adhyaya, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: This Yoga is taken in the form of Vikeshika, pata or varti means a lint, that is a fine fabric mesh or a gauze used in dressings. Manjishtadi vikeshika seems to have the qualities of an ideal contact layer dressing, desired healing within 21days of time period. |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Extent of burn will be decided with the help of Boyles Rule of Nine and Lund and Browders chart, through which the percentage of damage of surface area and depth will be estimated. 1. Subjects up to 30% burns, 1° and 2° degree burns, Partial thickness burns, 2. Flash, flame, contact, scald & chemical burns. 3. Irrespective of age, gender & occupation (Consent for subjects aged between 2 to 21 years, a well informed written consent will be taken from parent or guardian) 4. Medico legal cases will be included after medico legal case registration. |
|
| ExclusionCriteria |
| Details |
1.Subjects with more than 30% burnt area. 2. 3° and 4° burns. 3. Deep burns and if vital organs are involved like facial and genital. 4. Subjects with Mamsaavalamba, Gatravislesa, Sira snayu sandhi asthi vyapada atimatram, Jwara, Daha, Pipasa, Murcha. 5. Radiation 6. Cold burn. 7. Electrical burn |
|
|
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 |
| Reduction in the size of burn wound, pain and burning sensation |
7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the classical signs and symptoms of Dagdha vrana, exudate amount, skin surrounding the wound, peripheral tissue edema and pigmentation. |
21st day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS PUT FORWARD TO EVALUATE THE EFFICACY OF MANJISHTADI VIKESHIKA IN THE MANAGEMENT OF AGNI DAGDHA VRANA WITH SPECIAL REFERENCE TO 1ST AND 2ND DEGREE BURNS COMPARISON WITH PARAFFIN GAUZE.
HYPOTHESIS
1.NULL HYPOTHESIS H0:- MANJISHTADI VIKESHIKA IS EQUALLY EFFECTIVE TO PARAFFIN GAUZE IN THE MANAGEMENT OF AGNI DAGDHA VRANA
2.ALTERNATE HYPOTHESIS H1:- MANJISHTADI VIKESHIKA IS MORE EFFECTIVE THAN PARAFFIN GAUZE IN THE MANAGEMENT OF AGNI DAGDHA VRANA
H2:- PARAFFIN GAUZE IS MORE EFFECTIVE THAN MANJISHTADI VIKESHIKA IN THE MANAGEMENT OF AGNI DAGDHA VRANA |