| CTRI Number |
CTRI/2024/05/067389 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Shadbindu ghrita nasya along with Pippalyadi rasayana orally in Management of Vataja Pratishyaya |
|
Scientific Title of Study
|
Clinical evaluation of Shadbindu ghrita nasya along with Pippalyadi rasayana orally in management of Vataja Pratishyaya-an open labelled single arm study |
| 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 Madhu Kumawat |
| Designation |
PG Scolar |
| Affiliation |
Government Akhandanand ayurveda college |
| Address |
OPD NO 3, Department of Shalakya tantra, Government akhandanand ayurved college, Bhadra, Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
8739801686 |
| Fax |
|
| Email |
madhukumawat8739@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Payal Sharma |
| Designation |
Lecturer |
| Affiliation |
Government Akhandanand ayurveda college |
| Address |
OPD NO 3, Department of Shalakya tantra, Government akhandanand ayurved college, Bhadra, Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
7597340471 |
| Fax |
|
| Email |
sharma.payal169@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Sharma |
| Designation |
Lecturer |
| Affiliation |
Government Akhandanand ayurveda college |
| Address |
OPD NO 3, Department of Shalakya tantra, Government akhandanand ayurved college, Bhadra, Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
7597340471 |
| Fax |
|
| Email |
sharma.payal169@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda College,Bhadra, Ahmedabad 380001 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda College Ahmedabad |
| Address |
Government Akhandanand Ayurveda College & Hospital Bhadra Ahmedabad |
| 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 Madhu Kumawat |
Government akhandanand ayurveda college, Ahmedabad |
OPD NO 3, Department of Shalakya tantra, Government akhandanand ayurved college, Bhadra, Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT |
8739801686
madhukumawat8739@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J988||Other specified respiratory disorders. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Rasayan , Reference: Sahastram yoga, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 24(g), Frequency: bd, Bhaishajya Kal: Abhakta, 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 |
Patient having the Symptoms of Kshavathu[Sneezing], Tanu srava[Thin discharge from nose], Gala Talu Ostha sosha[Dryness in throat ,lips and palate], Shankha Nistoda/Shirahshool[Headache], Anadhanasa [Nasal obstruction], Swarabheda [Hoarseness of voice], Pihita Nasa [Foreign body sensation in Nose] of Vataja Pratishyaya. |
|
| ExclusionCriteria |
| Details |
1.Patients suffers from any chronic debilitating disease like Diabetes mellitus, Tuberculosis, Chronic Sinusitis, Nasal polyps, laryngeal cancer, vocal cord cancer, vocal cord paralysis and with other nasal pathology will be excluded from study.
2.Pregnant ladies and lactating mothers.
3.Nasya Karma Ayogya.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of Vataja Pratishyaya. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
19/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Acharya Sushruta and Vagbhatta mentioned five types of Pratishyaya. Vataja Pratishyaya is the first and foremost among five type of Pratishyaya.Due to these nidana sevana, vatadi dosha along with Rakta get vitiated. Continuous dosha prakopak nidan sevana leads to Balahani also. After getting the Doshas Sthanasamshrya in Nasha and Shirah prdesh they develop symptoms like kshavathu [Sneezing], Tanu srava [Thin discharge from nose], Gala-Talu-Ostashosha [dryness in throat, lips and palate] Shankha Nistoda/Shirahshool [Headache], Anadhanasa [Nasal obstruction], Swarabheda [Hoarseness of voice], Pihita Nasa [Foreign body sensation in nose].
We need to search ayurvedic management which is not supposed to be have any adverse effects and can better manage Vataja Pratishyaya. So the study is planned to find the management from the ancient texts which is effective and cheap. Nasya is mentioned as basic line of treatment for Urdhvajatrugata Roga. Nasya with Shadbindu Ghrita supposed to be effective in management of Vataja Pratishyaya. Pippalyadi Rasayana has Rasayana and Pinasahara properties. Due to having rasayana properties, it will enhance the Rogi bala. So Pippalyadi Rasayana is supposed to be effective in the management of Vataja Pratishyaya. |