| CTRI Number |
CTRI/2023/05/052289 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Application of Sarjarasa Malahara(Ointment) in the management of Padadari (CRACK HEEL)" |
|
Scientific Title of Study
|
"A Clinical study to evaluate the effect of Sarjarasa Malahara Lepa in the management of Padadari W.S.R to Crack heel" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MISS CHAITRA C CHALAGERI |
| Designation |
STUDENT |
| Affiliation |
SDM TRUSTS AMC TERDAL |
| Address |
SDM TRUSTS AMC TERDAL
DIST BAGALKOTE
Bagalkot
KARNATAKA
587315
India |
| Phone |
7483666320 |
| Fax |
|
| Email |
chaitra.chalageri9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata B Waddar |
| Designation |
Associate professor |
| Affiliation |
SDM TRUSTS AMC TERDAL |
| Address |
SDM TRUSTS AMC TERDAL
DIST BAGALKOTE
Bagalkot
KARNATAKA
587315
India |
| Phone |
8105401470 |
| Fax |
|
| Email |
sujata.bw@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MISS CHAITRA C CHALAGERI |
| Designation |
STUDENT |
| Affiliation |
SDM TRUSTS AMC TERDAL |
| Address |
SDM TRUSTS AMC TERDAL
DIST BAGALKOTE
Bagalkot
KARNATAKA
587315
India |
| Phone |
7483666320 |
| Fax |
|
| Email |
chaitra.chalageri9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya Tantra SDM TRUSTS Ayurvedic medical college and Hospital TERDAL |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| CHAITRA C CHALAGERI |
SDM TRUSTS AMC, TERDAL |
DEPARTMENT OF SHALYA TANTRA
Bagalkot
KARNATAKA |
7483666320
chaitra.chalageri9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, SDM TRUSTS AMC TERDAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: , Rasatantrasara va Siddhaprayogasangraha, Procedure details: Foot bath will be advised and asked to dry of feet, Sarjarasa Malahara
will be asked to apply at affected site with help of cotton spatula twice a
day.
Post procedure- patient will be advised to avoid exposure to dust and
bare foot walk.)
(1) Medicine Name: SARJARASA MALAHARA, Reference: , Rasatantrasara va Siddhaprayogasangraha, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of occupation and foot wear
Lakshana of Padadari such as
• Padayo Kurute daari (Cracks in feet),
• Saruja (With pain),
• Ruksha(Dryness of feet)
|
|
| ExclusionCriteria |
| Details |
- Patient with history of allergy.
- Patients with Psoriasis and Eczema.
- Any infection intervening condition will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief of pain
Reduction in roughness and dryness of feet
Reduction in cracks of feet |
1st follow on 15th day
2nd follow up on 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCED CRACKS |
15 DAYS |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/05/2023 |
| 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="23"
Months="3"
Days="30" |
|
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
|
|
Brief Summary
|
Ayurveda is the science of life which not only deals with the health and illness of human being but also considers the lifestyle and cosmetic aspects . There is lot of difference between today’s life style and ancient lifestyle so the application of ayurvedic principles should be modified and applied according to disease condition. Ancient ayurvedic principles must be retestified because pure metal regains its shiny nature by its polishing.For that purpose we need to do research. Ayurveda considers certain diseases under Kshudra Kushta.Many authors like Acharya Charaka, Acharya Sushruta ,Acharya Vagbhata etc mentioned few diseases under Kshudrarogas. Few authors like Madhava nidana, Sushruta, Yogaratnakara, Bhavaprakash kept Padadari under Kshudraroga. Padadari is a condition where vata gets aggravated and gets sthanasamsraya in the foot region. It is seen in persons who are walking excessively and wearing improper footwears or barefoot walkers, expose to cold water, even unhygienic conditions like expose to dust, germs,dirt leads to appearance of symptoms like dryness of feet, cracks, flaring patches, itchy skin, pain in the palms and soles. This can be compare to with the cracked heels/heel fissures. When the fissures are deep, they get bleed and become painful later may get infected. It diminishes the beauty of feet. In Ayurveda various treatment principles are explained like administration of drugs internally, external application of drugs, padabhyanga and all. Many drugs like Vranaropaka, Krimighna, Kushtahara selected for the treatment procedure in ancient days. By considering these all in Rasatantrasara va Siddhaprayogasangraha mentioned treatment protocol in the management of Padadari. Application of Sarjarasa Malahara used in the case . |