| CTRI Number |
CTRI/2022/07/043828 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
03/07/2022 |
| 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 on Vataja Pratishyaya by using Anu Taila with Trikatu Churna and Vidaryadi Ghrita with Trikatu Churna |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Anu Taila Nasya With Trikatu Churna Orally And Vidaryadi Ghrita Nasya With Trikatu Churna Orally In Vataja Pratishyaya |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi |
| Designation |
P.G. Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Address |
O.P.D. No. 3, Department of Shalakya Tantra, Patanjali Ayurvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
08894285074 |
| Fax |
|
| Email |
dr.rohitnidhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daya Shankar Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Address |
O.P.D. No. 3, Department of Shalakya Tantra, Patanjali Ayurvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
08194028515 |
| Fax |
|
| Email |
dayaayush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daya Shankar Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Address |
O.P.D. No. 3, Department of Shalakya Tantra, Patanjali Ayurvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
08194028515 |
| Fax |
|
| Email |
dayaayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurved Hospital |
| Address |
Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nidhi |
Patanjali Ayurved Hospital |
O.P.D. No. 3, Department of Shalakya Tantra, Patanjali Ayurvedic Hospital, Patanjali Bhartiya Ayurvijyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL |
8894285074
dr.rohitnidhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astang Hridaya, Procedure details: Given for 7 days)
(1) Medicine Name: Anu Tail, Reference: Acharya Charaka, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astang Hridaya, Procedure details: Given for 7 days)
(1) Medicine Name: Vidaryadi Ghrita, Reference: Astang Hridaya, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: trikatu churna, Reference: bhava prakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: trikatu churna, Reference: bhava prakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with signs and symptoms of Vataja Pratishyaya (Allergic rhinitis) as explained in classics.
2) Patients Yogya for Nasya Karma.
3) Patients willing to participate in study through written consent. |
|
| ExclusionCriteria |
| Details |
1) Patients below 8 and above 70 yrs.
2) Patients with chronic infective respiratory diseases, other conditions like Nasal polyp, Tumors etc.
3) Patients with systemic illness like T.B., Diabetes Mellitus, Bronchial Asthma etc.
4) Patients Ayogya for Nasya Karma.
5) Patients not willing to participate. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS:
Anaddhapihita Nasa (Nasal obstruction)
Tanusrava (Watery nasal discharge)
Kshavathu (Sneezing)
Shirahshoola (Headache)
Swaropaghata (Hoarseness of voice)
OBJECTIVE PARAMETERS:
Spatula Test
Anterior Rhinoscopy Findings |
At baseline/Before intervention of Anu Taila Nasya with Trikatu Churna Orally and Vidaryadi Ghrita Nasya with Trikatu Churna Orally |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS:
Anaddhapihita Nasa (Nasal obstruction)
Tanusrava (Watery nasal discharge)
Kshavathu (Sneezing)
Shirahshoola (Headache)
Swaropaghata (Hoarseness of voice)
OBJECTIVE PARAMETERS:
Spatula Test
Anterior Rhinoscopy Findings |
After 5 weeks/After intervention of Anu Taila Nasya with Trikatu Churna Orally and Vidaryadi Ghrita Nasya with Trikatu Churna Orally |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/07/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this trial, we are selecting the patients of vataja pratishyaya in which we will do the intervention in two groups (20 patients in each group). in one group, we will given ayurvedic drug trikatu churna orally with ayurvedic therapy nasya by anu tail, where as in another group, we will given ayurvedic drug trikatu churna orally with ayurvedic therapy nasya by vidaryadi ghrita. assessment will be done on the besis of subjective and objective parameters and scoring will be done before and after the treatment. |