| CTRI Number |
CTRI/2026/01/100522 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of combination of Marich and Goghrit in Patients Suffering from Sheetpitta |
|
Scientific Title of Study
|
Randomized clinical controlled study to evaluate the Efficacy and Immunological impact of Maricha Goghrita Yoga in Sheetpitta |
| 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 Shweta Chandrashekhar Moon |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D. Pol foundation YMT Ayurvedic Medical College |
| Address |
OPD No.08 Dr. G. D. Pol foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9021281977 |
| Fax |
|
| Email |
shwetamoon022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Pandey |
| Designation |
Associate Professor |
| Affiliation |
Dr. G. D. Pol foundation YMT Ayurvedic Medical College |
| Address |
OPD No.08 Dr. G. D. Pol foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820006082 |
| Fax |
|
| Email |
drpandeymahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Pandey |
| Designation |
Associate Professor |
| Affiliation |
Dr. G. D. Pol foundation YMT Ayurvedic Medical College |
| Address |
OPD No.08 Dr. G. D. Pol foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820006082 |
| Fax |
|
| Email |
drpandeymahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G. D. Pol foundation YMT Ayurvedic Medical College, Institutional Area Sector 4,Kharghar, Navi Mumbai.410210 Raigarh Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Chandrashekhar Moon |
| Address |
OPD No.08 Kayachikitsa Department,Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar, Navi Mumbai 410210 Raigarh Maharashtra 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 Shweta Chandrashekhar Moon |
Dr. G. D. Pol foundation YMT Ayurvedic Medical College |
OPD No. 08 Kayachikitsa Department, Dr. G. D. Pol foundation YMT Ayurvedic Medical College, Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
9021281977
shwetamoon022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. G.D. Pol Foundation YMT Ayurvedic Medical College and Charitable Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D894||Mast cell activation syndrome andrelated disorders. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | TAB. FEXOFENADINE | 120MG Once a day in the morning | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Maricha Goghrita Yoga, Reference: Bhaishajyaratnavali Sheetapittachikitsa Adhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: 6gm |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patients with history of chronic urticaria
2. Patients irrespective of gender will be included and who are willing to take medicine
3. Age group within 18-60 years
4. UAS more than or equal to 7 and less than or equal to 27
5. Patients having any signs and symptoms of Sheetpitta |
|
| ExclusionCriteria |
| Details |
1. Known case of dermatitis
2. Known case of active allergic conditions other than chronic urticaria
3. History of Angioedema
4. History of anaphylaxix to medicine
5. Known case of Immunocompromised patients or subjects on immunosupressive drugs.
6. Patients suffering from severe systemic illness
7. Pregnant and lactating females
8. Patient taking Anticoagulant
9. History of any Bleeding Disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment the clinical efficacy of Maricha Goghrita Yoga in reducing the symptoms of Sheetpitta. |
Week 1,2,3,4,5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of immunological effect of Maricha Goghrita Yoga through Change in serum IgE levels & Absolute Eosinophil Count |
Week 1,3 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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 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 present study, Randomised clinical controlled study to evaluate the efficacy and immunological impact of Maricha Goghrita Yoga in Sheetpitta is planned to assess the clinical efficacy and immunological impact of Maricha Goghrita Yoga in patients of Sheetpitta (Chronic Urticaria). A total of 60 patients will be enrolled and randomly divided into two equal groups of 30 patients each. Group A (experimental Group) will receive Maricha Goghrita Yoga, while Group B (control Group) will receive Tab. Fexofenadine. Subjective assessment will be carried out using Urticarial Activity Score(UAS), including Daha, Toda, Kandu, Chardi, and Jwar. Objective assessment willl include Serum IgE level and Absolute Eosinophil Count (AEC). Evaluation will be performed at five visits (Visit 1 to Visit 5) to asssess clinical improvement and immunological changes. |