| CTRI Number |
CTRI/2025/04/084118 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate The Efficacy Of Panchmool Siddha Milk As Pathya In Chronic Rhinitis |
|
Scientific Title of Study
|
A Randomised Control Trial To Evaluate The Efficacy Of Panchmool Siddha Ksheer As Pathya In Peenasa |
| 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 Dinesh Kumar Saini |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Room No. 201 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9929306621 |
| Fax |
|
| Email |
dks992930@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Professor And HOD |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Room No. 205 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Professor And HOD |
| Affiliation |
National Institute Of Ayurveda Jaipur |
| Address |
Room No. 205 Department Of Swasthavritta Evam Yoga National Institute Of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
|
Source of Monetary or Material Support
|
| N/A |
| National Institute of Ayurveda, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda Jaipur |
| Address |
National Institute Of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan, Pin code: 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 Dinesh Kumar Saini |
National Institute of Ayurveda |
Jorawar singh gate amber road jaipur 302002
Jaipur
RAJASTHAN |
9929306621
dks992930@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: NASAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: lakshmi vilas ras, Reference: bhaisaijyaratnavali, Route: Oral, Dosage Form: Rasayoga, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: sitopaladi churna, Reference: charak chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: honey), Additional Information: -(3) Medicine Name: vyoshaadi vati, Reference: sharngdra samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: -(4) Medicine Name: gojihwadi kwath, Reference: shidhyoga sangrah, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -(5) Medicine Name: chitrak haritaki, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: lukewarm water ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: lakshmi vilas ras, Reference: bhaisaijyaratnavali, Route: Oral, Dosage Form: Rasayoga, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: sitopaladi churna, Reference: charak chikitsa,, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -honey), Additional Information: -(3) Medicine Name: vyoshaadi vati, Reference: sharngdra samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -(4) Medicine Name: gojihwadi kwath, Reference: shidhyoga sangrah, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -(5) Medicine Name: chitrak haritaki, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -(6) Medicine Name: panchmool siddha ksheer , Reference: sharangdhar samhita , Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Person between 18 to 60 year of age and irrespective of gender
person having symptoms of peenasa
patients having symptoms of rhinitis more than or equal to 12 weeks |
|
| ExclusionCriteria |
| Details |
Use of oral antibiotics antihistamines or oral steroids
patients having any systemic and metabolic diseases
patient with co morbidity affecting mental or physical health
Abuse of drugs and alcohol addiction of tobacco
pregnancy and lactation
history of covid 19 infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gandhanash Symptom of peenasa |
0 and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| others symptoms of peenasa |
0 & 4 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="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
|
N/A |