| CTRI Number |
CTRI/2025/05/087833 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of narayan tail navan nasya in the management of
Ardit wsrto Bell’s Palsy
|
|
Scientific Title of Study
|
Randomised open control clinical study to evaluate the efficacy of
narayan tail navan nasya in the management of ardit w.s.r. to bell’s
palsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrunal Anil Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research centre Kodoli Panchkarma department OPD kodoli Tal Panhala Dist Kolhapur State Maharashtra 416114 India
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala Dist kolhapur state maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9075516032 |
| Fax |
|
| Email |
mrunalpatil2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Ingavale Abhijeet Subhashrao |
| Designation |
Reader |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre |
| Address |
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala Dist Kolhapur
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822919000 |
| Fax |
|
| Email |
abhijeetingavale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Ingavale Abhijeet Subhashrao |
| Designation |
Reader |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre |
| Address |
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala Dist kolhapur
Yashwant ayurvedic college post graduate training and research centre Kodoli Tal Panhala Dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822919000 |
| Fax |
|
| Email |
abhijeetingavale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic college post graduate training and research
centre,kodoli Tal Panhala Dist kolhapur 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Mrunal Anil Patil |
| Address |
Panchkarma OPD and IPD ground floor Panchkarma department Yashwant Ayurvedic college post graduate training and research centre Kodoli Tal Panhala Dist kolhapur416114 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vd Mrunal Anil Patil |
Yashwant ayurvedic college post graduate training and research centre Kodoli |
Yashwant ayurvedic college post graduate training and research centre panchkarma department OPD No 13 Kodoli Tal Panhala Dist Kolhapur State Maharashtra 416114,
Kolhapur
MAHARASHTRA |
9075516032
mrunalpatil2018@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:G510||Bells palsy. Ayurveda Condition: ARDITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang hriday sutrasthan 20/10, Procedure details: 8drops in each nostril for 21 days)
(1) Medicine Name: Narayan Taila, Reference: Sharangdhar samhita madhyam khanda 9, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang hriday sutrasthan 20/10, Procedure details: 8drops in each nostril for 21 days)
(1) Medicine Name: Karpasasthyadi taila, Reference: Sahastrayoga, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting sign and symptoms of ardita mukhavakrata netrastabdhata waksang lalasrav kshawathunigrah nasavakrata , Patient fit for nasya karma ,
Patient willing to give inform consent and able to participate in study |
|
| ExclusionCriteria |
| Details |
Associated with any deformities or Fascial Fractures.
Patients under gone any major surgery.
Patients with other systemic disorders and Serious illness.
Having cardiovascular disease, Pulmonary TB Pregnancy HIV Acute Hemiplegia Acute Paraplegia.
CA related to face
Subjects with hereditary disorders and Autoimmune disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will check Reduced in waksang ashrusrava lalasrava mukhardha vakrata |
21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete cure in waksang ashrusrava lalasrava mukhardha vakrata |
21days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
14/06/2027 |
| 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 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
|
Randomised open control clinical study to evaluate the efficacy of Narayan Tail Nasya in Ardit w.s.r. to Bell’s Palsy study will be carried in panchkarma department opd at Yashwant Ayurved Medical College and hospital kodoli The Observation will be drawn on the basis of symptoms after treatment given |