| CTRI Number |
CTRI/2025/04/084295 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study of an ayurvedic preparation pippalyadi vati in the management of disease
Vataj pratishyay which is correlated with disease acute rhinitis in modern science |
|
Scientific Title of Study
|
Open Randomized Control Clinical Trial of Pippalyadi vati in
Vataja Pratishyaya with special reference to Acute Rhinitis
(COMMON COLD) |
| 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 Poonam Laxman Powar |
| Designation |
Post Graduate Student |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta |
| Address |
OPD no 5 ENT (Shalakya),Ground Floor Dhanvantri Hospital Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9324250360 |
| Fax |
|
| Email |
Poonampowar10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayvant Kharat |
| Designation |
Associate professor, Shalakya Department |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Centre Ashta Tq Walwa |
| Address |
5th Floor Department of Shalakya Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayvant Kharat |
| Designation |
Associate professor, Shalakya Department |
| Affiliation |
Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Centre Ashta Tq Walwa |
| Address |
5th Floor Department of Shalakya Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India
MAHARASHTRA
416301
India |
| Phone |
9604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon. Annasaheb Dange Ayurved College and PG Reasearch Centre , Ashta ,Tal. Walwa Dist. Sangli |
|
|
Primary Sponsor
|
| Name |
Dr Poonam Laxman Powar |
| Address |
5th Opd no Opd ground floor Shalakya (ENT)
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India |
| Type of Sponsor |
Private 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 Poonam Laxman Powar |
Dhanwantari Ayurvedic Hospital |
Hon. Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Centre Ashta Tq Walwa 416301
Sangli
MAHARASHTRA |
9324250360
Poonampowar10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon. Annasaheb Danger Ayurved Medical College and Post Graduate Research Centre Ashta INSTITUTIONAL ETHICS COMMITEE |
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 | Drug | Classical | | (1) Medicine Name: Pippalyadi vati , Reference: Ashtang Hriday , Sutrasthan , Pippalyadi Gana , shlok No. 40-41, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Fexofenadine 60 mg Tablet | Fexofenadine 60 mg 1 BD After meal for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from theVatajaPratishyaya (Acute Rhinitis-common
cold).
2. Patients of Age Group 18 To 60 years, irrespective of their gender,
religion, occupation.
3. All patients having signs and symptoms -
1.Aanaddhapihita (Nasal Obstruction)
2.Tanustrava (Rhinorrhoea)
3. Kshavathu (Sneezing)
4. jwara (fever) |
|
| ExclusionCriteria |
| Details |
1. Pregnant women and children
2. History of congenital disorder of nose
3. Known cases of chronic specific infective rhinitis, syphilis, leprosy,
tuberculosis, Lupus vulgaris, fungal infections,
4. Patients with nasal polyp, neoplasm |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pippalyadi Vati is More Effective Than Fexofenadine in Acute Rhinitis (Common Cold ) |
1 BD for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pippalyadi vati is equally effective as Fexofenadine in Acute Rhinitis (Common Cold). |
1 BD for 7 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
21/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/04/2025 |
| 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 Yet Recruiting |
| 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
|
Based on the physician diagnosis incidence of Acute Rhinitis in India ranges
between20% to 30%. 17 Studies have shown that prevalence of Acute
rhinitis has been increasing in India over past few years. Thus the study will
be carried out to find out the solution for the relief from Acute Rhinitis
(VatajaPratishyaya).
The disease VatajaPratishyaya which is due to vitiation of vatadosha in
nasa region is comparable with Acute Rhinitis which is more common now
a day due to increased pollution and changes in lifestyle.VatajaPratishyaya
has symptoms like Aanaddhapihita, Tanustrava, Kshawathu,which are also
present in Acute Rhinitis(common cold) as a nasal blockage, rhinorrhoea,
sneezing.
Treatment for the Acute Rhinitis(common cold) is antihistamines and
steroids etc and their side effects are drowsiness,dizziness and headache.
Ayurveda has much effective treatment modalities for VatajaPratishyaya.
Hence the present study will be carried out to evaluate the efficacy of
PippalyadiVatiinVatajaPratishyaya. |