| CTRI Number |
CTRI/2025/08/093504 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on the Effect of Mangalyam Tail Nasya in treatment of Facial Palsy (Ardita) |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE EFFICACY OF MANGALYAM TAIL NASYA IN THE MANAGEMENT OF ARDITA (FACIAL 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 |
Dr Garima Singh |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.) |
| Address |
PG Department of Panchakarma, Room no.111 Pt Khushilal Sharma Government (Autonomous)Ayurveda College and Institute Science Hills Bhopal (M.P.)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9893079946 |
| Fax |
|
| Email |
garimasingh97.gs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamini Soni |
| Designation |
Professor |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.) |
| Address |
PG Department of Panchakarma, Room no.111 Pt Khushilal Sharma Government (Autonomous)Ayurveda College and Institute Science Hills Bhopal (M.P.)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
8770037353 |
| Fax |
|
| Email |
skamini382@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Singh |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal (M.P.) |
| Address |
PG Department of Panchakarma, Room no.111 Pt Khushilal Sharma Government (Autonomous)Ayurveda College and Institute Science Hills Bhopal (M.P.)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9893079946 |
| Fax |
|
| Email |
garimasingh97.gs@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Panchakarma, Pt. Khushilal Sharma Government (Autonomous)Ayurveda College and Institute Science Hills Bhopal (M.P.) India 462007 |
|
|
Primary Sponsor
|
| Name |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal (MP) |
| Address |
PG Department of Panchakarma, Pt. Khushilal Sharma Government (Autonomous)Ayurveda College and Institute Science Hills Bhopal (M.P.) India 462007 |
| Type of Sponsor |
Government funding agency |
|
|
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 Garima Singh |
Pt. Khushilal Sharma Ayurveda College and Institute, Bhopal (M.P.) |
PG Department of Panchakarma, Room no.111 Pt. Khushilal Sharma Government (Autonomous)Ayurveda College and Institute Science Hills Bhopal (M.P.)
Bhopal
MADHYA PRADESH |
9893079946
garimasingh97.gs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Pt. Khushilal Sharma Government Ayurveda Institute Bhopal (M.P.) |
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 | Comparator Arm (Non Ayurveda) | | - | Physiotherapy | Conventional physiotherapy for facial palsy, administered daily for a period of 21 days under supervision of a qualified physiotherapist.
| | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charak Siddhi Sthan 9/88, Procedure details: 15 patients of this group will be treated with Nasya karma using Mangalyam tail. 8,8 drops in each nostril.)
(1) Medicine Name: Mangalyam tail, Reference: Gadnigrah Nasya Adhikar verse 42 to 48, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 16(drops), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
Age 19 to 68 years.
patient those having Lakshana of Ardita for less than 1 year.
Patients willing to sign written consent for participation in the study.
Patient fit for Nasya Karma. |
|
| ExclusionCriteria |
| Details |
The chief exclusion criteria are tumor, intracranial hemorrhage, bilateral facial palsy.
Pregnant women and lactating mothers.
Patients with uncontrolled diabetes mellitus (DM2). |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study we would be able to demonstrate the effect of Mangalyam tail nasya in the management of Ardita (Facial palsy). |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that this study would be able to provide conclusive inputs to assess the efficacy of the Ayurvedic management of Ardita (Facial paralysis) |
11 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/12/2025 |
| 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="0"
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
|
From this study, it is expected that at the end of the study we would be able to demonstrate the effect of Mangalyam Tail Nasya in the management of Ardita (Facial Palsy). It is further expected that this study would be able to provide conclusive inputs to assess the efficacy of the Ayurvedic management of Facial Palsy. |