| CTRI Number |
CTRI/2025/03/081951 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare efficacy of Shatahvadi Taila Nasya and Nimbadi Guggulu Orally in Kaphaja Shiroroga (Sinusitis). |
|
Scientific Title of Study
|
A Randomized Clinical Trial To Evaluate The Efficacy Of Shatahvadi Taila Nasya And Nimbadi Guggulu Orally In The Management Of Kaphaja Shiroroga W.S.R. To Sinusitis.
|
| 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 Anusuiya Meghwal |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India |
| Address |
OPD no. 9 and 10, PG dept of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College, Near Radaji Circle Udaipur(313001),Rajasthan,India
Madan Mohan Malviya Government Ayurved College
Udaipur(313001)
Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890359350 |
| Fax |
|
| Email |
anusuiyamegh1898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India |
| Address |
OPD no. 9 and 10, PG dept of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College, Near Radaji Circle Udaipur(313001),Rajasthan,India
Madan Mohan Malviya Government Ayurved College
Udaipur(313001)
Rajasthan
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India |
| Address |
P.G. Department of Shalakya Tantra. Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India
Madan Mohan Malviya Government Ayurved College
Udaipur(313001)
Rajasthan
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India |
| 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 Anusuiya Meghwal |
Madan Mohan Malviya Government Ayurved College and Hospital, Udaipur |
O.P.D. No. 9 & 10, P.G.Department of ShalakyaTantra.
Madan Mohan Malviya Government Ayurved College Near Radaji Circle Udaipur(313001),Rajasthan,India
Udaipur
RAJASTHAN |
8890359350
anusuiyamegh1898@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE M.M.M. Govt. Ayurved College Ambamata Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: KAPAJA-SIROROGAH/KAPAJA SIROBITAPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nimbadi Guggulu, Reference: Bruhat Nighantu Ratnakara, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke Warm Water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Chakradatta Shiroroga Chikitsa, Procedure details: Medicated drops will be administered through nose)
(1) Medicine Name: Shatahvadi Taila, Reference: Chakradatta Shiroroga Chikitsa, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria which were based on the signs and symptoms of Kaphaja Shiro roga explained in classics and chronic sinusitis as per modern science.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women
2.Lactating women.
3.Patient suffering from diabetes.
4.Patients suffering from pain and facial swelling due to alveolar abscess,cellulitis of cheek, furuncle,trigeminal neuralgia, temporal arteritis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Kaphaja Shiroroga (Sinusitis) after treatment. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other associated symptoms. |
30th day |
|
|
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)
|
01/05/2025 |
| 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="0"
Months="1"
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 is a clinical trial to compare efficacy of Shatahvadi Taila Nasya and Nimbadi Guggulu on Kaphaja Shiroroga with special reference to Sinusitis . In this trial 2 groups each of 30 patients will be selected. Group A will be administered with Nimbadi Guggulu 2 BD with lukewarm water orally. Group B will be administered with Nimbadi Guggulu 2 BD with lukewarm water orally along with Shatahvadi Taila Nasya. |