| CTRI Number |
CTRI/2025/05/087435 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial To Study Importance Of Nidan Parivarjan In The Padadari With Upshayatamk Adhyan Of Goghrita |
|
Scientific Title of Study
|
Randomized Control Clinical Trial To Assess The Importance of Nidan Parivarjan In the Padadari with Upshayatamk Adhyan of Goghrita |
| 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 Jagruti Digambarrao More |
| Designation |
PG Student |
| Affiliation |
LRP Ayurvedic Medical College and Research Center , Urun Islampur |
| Address |
Room No 1 Rognidan Department LRP Ayurvedic Medical College And Hospital and Research Center Urun Islampur Taluka Walva District Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8605069130 |
| Fax |
|
| Email |
jagrutimore02018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhimanyu Patil |
| Designation |
Dean and Professor |
| Affiliation |
LRP Ayurvedic Medical College and Research center , Urun I |
| Address |
Room no 1 Rognidan Department LRP Ayurvedic Medical Collage And Hospital and Research Center Urun Islampur Taluk Walva District Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9960538603 |
| Fax |
|
| Email |
manyupatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagruti Digambarrao More |
| Designation |
PG Student |
| Affiliation |
LRP Ayurvedic Medical College and Research Center , Urun Islampur |
| Address |
Room No 1 Rognidan Department LRP Ayurvedic Medical College And Hospital and Research Center Urun Islampur Taluka Walva District Sangli
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA
415409
India |
| Phone |
8605069130 |
| Fax |
|
| Email |
jagrutimore02018@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital Research center Urun Islampur Taluka Walva District Sangli Pincode 415409 Maharasthra India |
|
|
Primary Sponsor
|
| Name |
Dr Jagruti Digambarrao More |
| Address |
LRP Ayurvedic Medical Collage and Hospital And Research Center Urun Islampur Tal. Walva Dist. Sangli 415409 Maharasthra India |
| 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 Jagruti Digambarrao More |
LRP Ayurvedic Medical College And Hospital |
Room no 1 Rodnidan Department LRP ayurvedic medical college and hospital research centre Urun Islampur Taluka Walva District Sangli 415409
Sangli
MAHARASHTRA |
8605069130
jagrutimore02018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre,Islampur |
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: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Goghrita , Reference: Kaiydevnighantu , Route: Topical, Dosage Form: Ghrita, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Trial Group study with nidan parivarjan and goghrita | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Goghrita , Reference: Kaiydevnighantu , Route: Topical, Dosage Form: Ghrita, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Control group study with goghrita |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients will selected irrespective of Religion,Occupation,Education,Socio economic status,Area of habitat.
Signs and symptoms of Padadari described in Samhita..Dari(Cracks),Vedana(Pain), Rukshata(Dryness) Itchy skin,hardness around the rim and cracks or fissures on the outer edge of the heel,deep fissures.
Patient willing to participate in clinical trial with written consent. |
|
| ExclusionCriteria |
| Details |
1.Severe bleeding with infected wounds
2.Gangrenous foot
3.Psoriasis in hands and foot
4.Patient not willing for clinical trial
5.Old Age |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Nidan parivarjan in the padadari with upshayatamk adhyan of goghrita |
21 days study with follow up on 7th,14th,and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study clinical effect of Goghrita in padadari |
21 days study with follow up on 7th,14th,and 21st day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
24/05/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Ayurveda is well known science of life since ancient times.In our samhitas, there are number of ways and means to make life healthier for diseased as well as fornon diseased. Even, much importance is given to Kshudrarogas also. Though kshudrarogas are not systemic and serious, they are quite troublesome and disturb the daily routine. There are various treatment modalities for kshudraroga in our Samhita. Acharya Sushruta, Madhavnidan, Bhavmishra have emphasized on the details of KshudraRogas. Kshudraroga includes various diseases which need to be discussed, as many of them disturb day to day life, as per prevalence in people. Padadari is a disease described in Ayurveda which occurs due to Vatadosha. Consumption of foods that aggravate vata, such as those that are dry, hot, and spicy, as well as certain behaviours, such as excessive walking, walking barefoot, walking in hard, inappropriate footwear, and a lack of regular routine belong to the Padadari. All of these hetus ultimately result in SthanikaVatadushti and enhance rukshatwa in the Padapradesha, resulting in Daree Padapradesha. It manifests with symptoms like dari,Saruja and Rukshta.Dry Feet can occur for a number of reasons including cold winter weather, dehydration or not drinking enough water, not moisturizing the feet. In Modern science Padadari is described as Cracked heel Ayurveda has widely mentioned about Nidan Panchak. This gives detailed information about Nidan, Purvaroop,Roop,Upashay and Samprapti . With the help of these five tools knowing the disease condition and pathology becomes easy for the vaidya to give proper treatment. |