| CTRI Number |
CTRI/2025/07/090096 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on effectiveness of shigru parn churna in treating vat kaphaj kushath in children |
|
Scientific Title of Study
|
A randomized controlled clinical study on effect of shigru (moringa oleifera) parn churna on vat kaphaj kushta in children age group 5 to 16 yrs w.r.t.phrenoderma. |
| 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 Dinesh bhagwatrao kakade |
| Designation |
MD scholar kaumarbhritya |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadipanchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003 Nashik MAHARASHTRA 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422385085 |
| Fax |
|
| Email |
dineshkakade1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Shinde |
| Designation |
Professor |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003 Nashik MAHARASHTRA 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8087370701 |
| Fax |
|
| Email |
vd.kirans11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Shinde |
| Designation |
Professor |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003 Nashik MAHARASHTRA 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8087370701 |
| Fax |
|
| Email |
vd.kirans11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadipanchvati nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Shree saptshrungi Ayurved mahavidhyalaya and hospitalkamalnagar hirawadi nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi Ayurved mahavidhyalaya and hospital kamalnagar hirawadi nashik 422003 |
| Type of Sponsor |
Private medical college |
|
|
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 Dinesh bhagwatrao kakade |
Shree saptshrungi ayurveda mahavidhyalaya and hospital Nashik |
Shree saptshrungi ayurveda mahavidhyalaya and hospital Nashik 422003
Nashik maharashtra
Nashik
MAHARASHTRA |
9422385085
dineshkakade1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC shree saptshrungi ayurveda mahavidhyalaya and hospital Nashik 422003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | SYP VITAMIN A | Two lacks IU | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shigru parn churna , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 28 Days, anupAna/sahapAna: Yes(details: Kshudra ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Demographic character children with age group 5 to 16 years All the patient having symptoms of phrenoderma irrespective of demographic character like sex religion
Clinical character patient complaining of
Keratic papule goosebumps on elbow and knees
Skin dryness fine scaling hyperpigmentation |
|
| ExclusionCriteria |
| Details |
Patient with another systematic disorder like congenital anomaly juvenile diabetis mellitus malignancy any other serious hematological disorder metabolic disease etc
Patient along with another skin disorder
Patient having vit A sensitivity
Patient with hypervitaminosis a
The patient whose parents or guardians are not ready to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce symptoms of vat kaphaj kushtha |
Seventh day, fourteenth Day, twenty oneth Day, twenty eighth day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of vat kaphaj kushtha |
28 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/07/2025 |
| 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="6"
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
|
Objective Primary Objective
To compare the effect of SHIGRU MORINGA OLEIFERA PARNA CHURN and vitamin A supplement in vat kaphaj kushta with respect to phrenoderma in children age group five to sixteen yrs
To study the effect of SHIGRU MORINGA OLEIFERA PARNA CHURN in VAT KAPHAJ KUSHTA To study tha effect of vitamin A in phrenoderma.
Secondary Objective
To study the literature of phrenoderma from modern literature.
To study the literature of vat kushata from Ayurved classical book To study the literature of SHIGRU MORINGA OLEIFERA PARN CHURN from Ayurved classical book Participant Five to sixteen years children with vat kaphaj kushtha meeting inclusion and exclusion criteria from opd and ipd of department of kaumarbhritya of shree saptshrungi ayurved mahavidhyala and hospital nashik Intervention 34 patient vitamin asyrup administer as per standard protocol 34 patient shigru parn churna administer according as per standard protocol Primary outcome to reduce the sign and symptoms of vat kaphaj kushtha Secondary outcome no recurrency of vat kaphaj kushtha Treatment duration 28 days Follow up : 0th, 7th, 14th,28th days Plan for Statistical Analysis
Patients will be observed before and after treatment. All observed data collected after the final assessment will be subjected to statistical analysis as mentioned below.
Subjective criteria- WILCOXON SIGN RANK TEST for comparison within the group and Mann whitney test between two group
As per requirement other tests will be applied. Discussion
Discussion will be done on the basis of data collected during the study
Conclusion
Conclusion will be drawn strictly on the basis of statistical analysis
Summary
Whole work will be summarized in the final dissertation.
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