| CTRI Number |
CTRI/2024/04/066319 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Effect of Sarshapa Yoga Lepa and Sarshapa Yoga Cream in Urticaria |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to Assess the Effect of Sarshapa Yoga Lepa and Sarshapa Yoga Cream on Sheetpitta (Urticaria) wsr to Bhrajaka Pitta |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeeta Parihar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Kriya Sharir National institute of Ayurveda amer road jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9784503615 |
| Fax |
|
| Email |
sangeetaparihar365@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarika Yadav |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Kriya Sharir National institute of Ayurveda amer road jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9467451607 |
| Fax |
|
| Email |
ysarika19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangeeta Parihar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
PG Department of Kriya Sharir National institute of Ayurveda amer road jaipur 302002
RAJASTHAN
302002
India |
| Phone |
9784503615 |
| Fax |
|
| Email |
sangeetaparihar365@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur 302002 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
NIA Jaipur |
| Address |
PG Department of Kriya Sharir National institute of Ayurveda amer road jaipur 302002 |
| Type of Sponsor |
Government 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 Sangeeta Parihar |
National Institute of Ayurveda Jaipur |
OPD IPD and PG Department of Kriya Sharir National Institute of Ayurveda Amer road jaipur 302002
Jaipur
RAJASTHAN |
09784503615
sangeetaparihar365@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: Sheetpitta, (2) ICD-10 Condition: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarshapa yoga Lepa, Reference: Bhaishjiye ratanavali, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: External application | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarshapa yoga cream, Reference: Bhaishjayaratanavali, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -External application cream |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subject between 18 to 40 year age group
Subject with the classical feature of Sheetpitta
Grade 1 to 3 of Urticaria Activity Score
|
|
| ExclusionCriteria |
| Details |
Person who are already diagnosed with other skin disorders like Eczema Psoriasis Subjects who are K/C/O Post Surgical Urticaria Giant Urticaria
Subjects who are already diagnosed with complication of uncontrolled Diabetes Mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Urticaria Activity Score of Sheetpitta |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Urticaria activity score of Sheetpitta
Changes in sign & symptoms of Sheetpitta (Kandu Mandala Saraga) & skin pH |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/06/2024 |
| Date of Study Completion (India) |
18/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
4
Role of Pathya Apathaya in Sheetpitta, ROLE OF DINACHARYA W.S.R. TO ABHYANGA AND SNANA FOR SKIN HEALTH PHYSIOLOGICAL ASPECT OF RAJASWALA PARICHARYA W.S.R. TO APAN VATA, Role Of Nidra In Relieving Mental Health |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The demographic and clinical observations of the clinical trial were presented using detailed tables and bar diagrams. Statistical analyses were conducted separately for subjective and objective parameters. For intragroup comparisons, the Wilcoxon Signed-Rank Test was applied to subjective variables, while Paired t-Test was used for objective variables. For intergroup comparisons, the Mann–Whitney U Test was applied to subjective parameters, and the Unpaired t-Test was used for objective parameters. The results revealed statistically significant improvements in Group B; however, the Sarshapa Yoga Cream group demonstrated superior efficacy compared to the Sarshapa Yoga Lepa group in reducing clinical symptoms. No adverse events were reported during the study period. The chapter further provided a conceptual interpretation of the clinical findings, contextualizing them within Ayurvedic theoretical constructs. Probable mechanisms of action of the test formulation were discussed. Additionally, the limitations of the study were addressed, acknowledging factors that may have influenced the generalizability and scope of the results. This chapter comprised two major segments. The first segment provided a structured synopsis of the research work, summarizing its conceptual foundation, methodology, key observations, and principal findings. The second segment presented the final conclusions drawn from the study, along with future recommendations aimed at enhancing the scope, rigor, and applicability of subsequent research initiatives in this field.
|