| CTRI Number |
CTRI/2025/03/083434 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of effect of application of Sthulapushpadi ointment and Sarjarasa ointment (malahara) with Siravedha in the management of Crack heels (Padadari) |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Sthulapushpadi ointment as against Sarjarasa ointment (malahara) with Siravedha in both groups in the management of Crack heels (Padadari) |
| 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. Prastuti Pramod Dhande |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center, Salod (H), Wardha, Maharashtra |
| Address |
OPD NO 14 DEPARTMENT OF SHALYATANTRA MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER SALOD(H) WARDHA
Wardha MAHARASHTRA 442001 India |
| Phone |
7774879508 |
| Fax |
|
| Email |
prastutidhande5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Sheetal Asutkar |
| Designation |
Professor & HOD |
| Affiliation |
MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER, SALOD(H), WARDHA |
| Address |
OPD NO 14 DEPARTMENT OF SHALYATANTRA MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER SALOD(H) WARDHA
Wardha MAHARASHTRA 442001 India |
| Phone |
7774879508 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Prastuti Pramod Dhande |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Center, Salod (H), Wardha, Maharashtra |
| Address |
OPD NO 14 DEPARTMENT OF SHALYATANTRA MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER SALOD(H) WARDHA
Wardha MAHARASHTRA 442001 India |
| Phone |
7774879508 |
| Fax |
|
| Email |
prastutidhande5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Center, Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education Wardha Maharashtra India |
| Address |
OPD 14 Department of Shalyatantra Mahatma Gandhi Ayurved Hospital and Research Center Salod (H) Wardha 442001 Maharashtra India |
| 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 Prastuti Dhande |
Mahatma Gandhi Ayurved College Hospital and Research Center Salod H Wardha Maharashtra |
OPD 14 Department of Shalyatantra Wardha MAHARASHTRA |
7774879508
prastutidhande5@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:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SARJARASA MALAHAR, Reference: RASA TARANGINI, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: STHULAPUSHPADI OINTMENT, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing with written informed consent.
Patients of either sex with age group 18 to 60 years of age.
Patients with all grades of pain, itching, dryness will be included.
Patients irrespective of sex, occupation and economic status will be included.
|
|
| ExclusionCriteria |
| Details |
1.Known cases of Diabetes mellitus, Plantar Keratoderma, HIV positive and Athlete’s Foot.
2. Subjects suffering from skin disorders like psoriasis, Hyperkeratotic eczema.
3. Subjects having excessive discharge from cracks of the heel.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
wound healing of padadari
|
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Topical Sthulapushpadi ointment is not more efficacious then topical Sarjarasa ointment (malahara) with Siravedha in both groups in the management of Padadari.
|
36 days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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 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
|
Cracked heels or Padadari is
important cosmetically and it affects the quality of life of a person when it
starts showing its symptoms. In modern science many treatments are there for
treating cracked heels like using Kleenex tissue to the affected area and then
painting over it with tincture benzoin compound. Many lotions, moisturizers,
healing and soothing creams are there in the market for the same. Many
pre-clinical studies has advised to wear cotton socks or liquid socks for the
same. In ayurvedic sciences various different modalities of treatment
are mentioned for Padadari like shodhan as well as shaman
chikitsa.
In Sushruta Samhita treatment
consists of snehana, swedana, siravedha, and application of various lepas
like ghrita, taila, vasa, majja, madhuchishti, and raal (6).
Sthulapushpa (Calendula officinalis) has known
effects of skin soothing, anti-inflammatory effects, skin moisturizing effects
which are importance causes for cracked heels (7). Along with sthulapushpa
other contents like kumari, haridra, nimba, narikel, tuttha, manjishtha will
be used in the formulation. Hence sthulapushpadi ointment will be used
in the research for its healing properties in padadari.
Two fundamental tenets of Ayurvedic medicine are Shodhana and Shaman chikitsa. Shodhan
chikitsa is the one where there is direct elimination of vitiated doshas. Amongst different shodhan treatments Raktamokshana is considered as best for Pitta and Rakta dushtijanya
vyadhis. Siravedhan is initial
line of treatment in managing shopha,
vedana, ruja etc.
Siravedha can
improve local microcirculation, eradicate algesic materials from the blood, and
encourage the restoration of harmed tissues and hence manage padadari (8).
It is
mentioned in Sushruta Sharirsthan regarding the site of Siravedha
in Padadari as vein situated two angula above the Kshipra marma
should be punctured. |