| CTRI Number |
CTRI/2024/12/078235 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on efficacy of Amruta Kwathpan and Tulasi Swaras Lep in the management of Sheetpitta with special reference to Chronic Urticaria |
|
Scientific Title of Study
|
Single arm clinical study to assess the efficacy of Amruta Kwathpan and Tulasi Swaras Lep in the management of Sheetpitta with special reference to Chronic Urticaria |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTejaswini Vitthalrao Patil |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur, kaumarbhritya department, OPD 2
Sangli
MAHARASHTRA
415409
India |
| Phone |
9657339835 |
| Fax |
|
| Email |
tejaswinivpatil1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Masaudaalam Mujawar |
| Designation |
HOD and Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur, kaumarbhritya department, OPD 2
Sangli
MAHARASHTRA
415409
India |
| Phone |
9823645588 |
| Fax |
|
| Email |
dr.masudaalam10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTejaswini Vitthalrao Patil |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital, PG Institute and Research center |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur, kaumarbhritya department, OPD 2
Sangli
MAHARASHTRA
415409
India |
| Phone |
9657339835 |
| Fax |
|
| Email |
tejaswinivpatil1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur
415409
|
|
|
Primary Sponsor
|
| Name |
Dr.Tejaswini Vitthalrao Patil |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and
Research center, Urun Islampur 415409
|
| 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 |
| DrTejaswini Vitthalrao Patil |
LRP Aurvedic medical college and hospital, PG Institute and Research center, Urun Islampur |
LRP Aurvedic medical
college and hospital,
PG Institute and
Research center, Urun
Islampur, Sangli,
Department of
kaumarbhritya, OPD 2
Sangli
MAHARASHTRA |
9372418504
tejaswinivpatil1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-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:L508||Other urticaria. Ayurveda Condition: UDARDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amruta, Reference: Yogratnakar Nidan (14/555), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: The Matra, dose of Kwath is given according to the weight of the baby(2) Medicine Name: Tulasi, Reference: Yogratnakar Nidan (14/555), Route: Topical, Dosage Form: Swaras/ Juice, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: patient can apply tulasi swaras lep three times a day also. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient diagnosed as sheetpitta as per sign and symptoms.
2.Gender as-irrespective of gender and socioeconomic status
3.age- above 6 to 12 years school age |
|
| ExclusionCriteria |
| Details |
Age above 12 yrs patients.
Patients who are not taking proper follow up.
3.Patients who have history of any other illness
4.Patients suffering from carcinoma, DM, HIV, HBSAg positive
5.Allergic contact dermatitis, psoriasis, fungal infection,Angioedema
6.Drug induced Urticaria.
7.Patients having history of or k/c/o- any chronic diseases .e.g. Heart diseases, Paraplegia, diabetes mellitus, hypertensive, Chronic kidney disease, liver disease, HIV
8.Hypersensitivity reactions to any drug.
9.Patients not willing for the treatment and not giving written consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Amruta kwathapan and tulasi swaras lep in the management of sheetpitta |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the sheetpitta in ayurvedic perspective
2. study amruta kwathpan and tulasi swaras lep in sheetpitta
3.to study the efficacy of Amruta kwathpan and tulasi swaras lep
4.to study chronic urticaria in detail |
7 to 15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/12/2024 |
| 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
|
Aims- to assess the efficacy of Amruta kwathpan and Tulasi swaras lep in the management of Sheetpitta 1.Primary objective -To Study the effect of Amruta Kwathpan and Tulasi Swaras Lepa in the management of Sheetpitta 2.Secondary objective 1) To study Sheetpitta in Ayurvedic perspective. 2) To study Amruta Kwath and Tulasi Swaras lep in detail in Sheetpitta 3) To study the efficacy of Amruta Kwath and Tulasi Swaras Lepa in Sheetpitta 4) To Study chronic Urticarial in detail
Type of Study Design: Single Arm Clinical Study.
Study Settings 1. All the clinical studies will be carried at our Ayurveda hospital OPD Age group between 6 to 12 year 2. Pathological investigation will be done at Ayurveda hospital, department of Pathology CBC abcolute eosinophil count and LFT as per Required.
Study Population
All the diagnosed cases of Shittapitta attending in our Ayurved hospital OPD and IPD. Study Duration Duration of entire study :- 18 months Duration of treatment :- 15 days Follow up:- 5th ,10th ,15th day
Diagnostic criteria:-
Patient will be diagnosed on the basis of clinical sign
ssessment criteria-
Subjective parameter are based on symptomatic relief i.e. mandala, kandu, toda,daha
The data obtained will be analyzed statistically.
Observation and Results: The observed Clinical Efficacy of treatment will be observed and recorded.
Discussion: Results will have discussed on the basis of collected data and statistical analysis.
Conclusion: It will be drawn strictly on the basis of statistical analysis.
Summary: The research study will be summarized in brief. Ethical Consideration: The study will be conducted in accordance with ethical guidelines and inform consent from participant. |