| CTRI Number |
CTRI/2026/03/105858 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To examine efficacy of Sita-madhukadi Yoga in urticaria ( Udarda). |
|
Scientific Title of Study
|
An open randomized controlled clinical trial to assess the efficacy of Sita-madhukadi Yoga in the management of Udarda with special reference to 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 |
Vd Madhav Prakash Kalbande |
| Designation |
PG Scholar, MD Kaychikitsa |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Training and Research center Gadhinglaj |
| Address |
Kayachikitsa OPD, Ground floor, LKR Hospital, P-2 MIDC Area,Shendri Mal,Gadhinglaj. Dist - Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9011701254 |
| Fax |
|
| Email |
madhavkalbande123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vibhavari Tukaram Kokane |
| Designation |
Professor of Kayachikitsa Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Training and Research center Gadhinglaj |
| Address |
Kayachikitsa OPD, Ground floor, LKR Hospital, P-2 MIDC Area,Shendri Mal,Gadhinglaj. Dist - Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420326846 |
| Fax |
|
| Email |
vibhavari.kokane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Madhav Prakash Kalbande |
| Designation |
PG Scholar, MD Kaychikitsa |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Training and Research center Gadhinglaj |
| Address |
Kayachikitsa OPD, Ground floor, LKR Hospital, P-2 MIDC Area,Shendri Mal,Gadhinglaj. Dist - Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9011701254 |
| Fax |
|
| Email |
madhavkalbande123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Training and Research center, Gadhinglaj ,P-2 MIDC Area,Shendri Mal,Gadhinglaj. Dist - Kolhapur |
|
|
Primary Sponsor
|
| Name |
Vd.Madhav Prakash Kalbande |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Training and Research center, Gadhinglaj ,P-2 MIDC Area,Shendri Mal,Gadhinglaj. Dist - Kolhapur |
| 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 Madhav Prakash Kalbande |
Late Kedari Redekar Ayurvedic Mahavidyalaya and Hospital Gadhinglaj |
Kayachikitsa OPD no.2 , Ground floor, LKR Hospital, P-2 MIDC Area, Shendri Mal, Gadhinglaj.
Pin-416502
Kolhapur
MAHARASHTRA |
9011701254
madhavkalbande123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Mahavidyalaya and PG Training and Research Center Gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L509||Urticaria, unspecified. Ayurveda Condition: UDARDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Agnimantha Yoga, Reference: Yogratnakar Shitpittaudardkothnidanam adhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Ghruta), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sita-madhukadfi Yoga , Reference: Gadnigrah Bhag 2 shitpittaudardakothnidanam adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign and symptoms of Udarda-Utsanga, Raag, Mandal, Kandu, Daha will be included in study.
Patient will be selected irrespective of sex and socio-economic status. |
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactating mothers will be excluded. Patient with history of known drug allergy will be excluded. Patient with other comorbidities like Dm, Uncontrolled HTN, HIV, TB, diagnosed cancer patient, Jaundice and immunocompromised status. Patient with skin disease with Psoriasis, Leprosy, Leucoderma, Severe Candidiasis will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mandal daha raga utsanga kandu these symptoms reduces |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of efficacy between sita-madhukadhi yoga and Agnimantha yoga |
14 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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 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
|
This study is open randomized controlled clinical trial to assess the efficacy of sita-madhukadhi yoga in the management of udarda with special reference to Urticaria. Total 60 Patient diagnosed with Urticaria of age 20 to 60 years irrespective of sex will be randomly selected for this trial and devided into two groups of 30 patients each. Trial Group- sita-madhukadi yoga 4gm TDS orally for 14 days control Group- agnimanth yoga 4 gm TDS orally for 14 days assessment will be done on the basis of subjective parameters ( Kandu, mandal, daha, raag, Utsanga ) and objective parameter ( absolute Eosinophil count) Data will be analysed and appropriate statistical test will be applied. Result will be presented.
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