| CTRI Number |
CTRI/2025/07/091655 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Topical Preparation for Cracked Heels |
|
Scientific Title of Study
|
PHARMACOGNOSTICAL STUDY AND CLINICAL EFFICACY OF SHIGRU(Moringa oleifera Lam) KANDA TWAK CHURNA LEPA IN PADADARI(CRACKED FOOT)-A FOLKLORE CLAIM |
| 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 Chaya Deepti Gampala |
| Designation |
Post Graduate Scholar |
| Affiliation |
Dr.Brkr Govt Ayurvedic College. |
| Address |
Dr.Chaya Deepti Department of Dravya Guna Dr.Brkr Govt Ayurvedic College.Erragadda Hyderabad email-gchaya.dr@gmail.com
Hyderabad
Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
9493698186 |
| Fax |
|
| Email |
gchaya.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGattu Swarupa Rani |
| Designation |
Professor |
| Affiliation |
Dr.Brkr Govt Ayurvedic Medical College. |
| Address |
Department of Dravyaguna,Dr.BRKR Govt Ayurvedic Medical College,Erragadda,hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9441905338 |
| Fax |
|
| Email |
gattusr135@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGattu Swarupa Rani |
| Designation |
Professor |
| Affiliation |
Dr.Brkr Govt Ayurvedic Medical College. |
| Address |
Department of Dravyaguna,First Floor,Dr.BRKR Govt Ayurvedic Medical College,Erragadda,hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9441905338 |
| Fax |
|
| Email |
gattusr135@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (CCRAS)
61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
CCRAS |
| Address |
Central Council for Research in Ayurvedic Sciences,
61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CCRAS |
Central Council for Research in Ayurvedic Sciences (CCRAS)
61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chaya Deepti Gampala |
Dr.Brkr Govt Ayurvedic Hospital. |
Room No-4 OPD,Department of Dravyaguna,Dr.Brkr Govt Ayurvedic Hospital.Erragadda, Hyderabad
Telangana
Hyderabad
TELANGANA |
09493698186
gchaya.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Government Ayurvedic Medical College |
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. Ayurveda Condition: PADAD, (2) ICD-10 Condition:L84||Corns and callosities. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SHIGRU KANDA TWAK CHURNA, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients Diagnosed With Clssical Signs And Symptoms of Padadari Ruja(pain) Rukshata(dryness),
Daree(cracks in the foot)
|
|
| ExclusionCriteria |
| Details |
1.Patients of Age Below 18 and Above 65 Years.
2.Patients Suffering From Vipadika,Psoriasis,Eczema
3.Patients With Allergic Conditions
4.Patients With Uncontrolled Diabetes
5.Patients Suffering With HIV and HBsAg
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain and Dryness in the Crackedfoot region along with Reduction in Number,Length and Depth of Cracks on the Foot |
At Baseline,Two Weeks,Four Weeks,six Weeks,Eight Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Improve the Quality of Life |
AtBaseline,2Weeks,4Weeks,6Weeks,8Weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| 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 Yet Recruiting |
| 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
|
The foundational disciplines of Ayurveda are intended to lessen suffering in people, this science discusses what normal and unhealthy human health statuses are. Shigru is a drug extensively used by tribal people of Kondareddi community of Eastern ghats of Andhra Pradesh. . Folklore remedies are the new diversion of ethnobotanical sciences which comes under empirical therapeutics. Ethnobotany has long been important in the development of innovative medications. Padadari is commonly occurring podiatric diseases in our society, it occurs in person who walks excessively, which eventually leads to Sthanika vata dusthi(localized vitiation of vata) due to increased Rukshatwa , in their Padapradesha leading to occurrence of Daree(cracks) at Padapradesha often associated with Ruja(pain) .Due to hectic schedules, people find it difficult to dedicate time to foot protection. This results in heel breaking and may cause frequent skin conditions like Padadari. One of the most prevalent and minor illnesses.It is more common in women than in men. It is one of the commonest diseases, highly prevalent in rural areas due to improper foot care. Most of the foot problems arise due to ignorance with regard to footcare.Poverty and illiteracy lead to improper footwear use. Sociocultural practices, such as barefoot waking, not wearing socks also contribute to heel fissures in Indian population.In most cases the problem is merely a annoyance and unattractive to look at, however when cracks or fissures become deep, standing, walking, or any pressure placed on the heel can be painful. DESIGNING PROGRAMME: a.Organoleptic,Phytochemical,Physiochemical and Clinical evaluation of SHIGRU (Moringa oleifera Lam) Stem Bark Powder in Padadari will be studied. b.A Single group of 30 subjects will be selected randomly from Dr.BRKR Govt Ayurvedic Hospital,Erragadda by Processing Signs and Symptoms of Padadari(Cracked foot) c.DOSE :Quantity sufficient , applied externally with oil once a day
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