| CTRI Number |
CTRI/2025/12/099028 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study on karpasasthyadi taila nasya and shirobasti in facial paralysis |
|
Scientific Title of Study
|
A Comparative Concepto Clinical Analysis on Ardite navanam murdhni tailam tarpanameva cha W.R.T.Karpasasthyadi taila |
| 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 Shobha |
| Designation |
PG scholar Department of samhita siddhanta |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital heggeri extension old hubballi |
| Address |
Ayurveda Mahavidyalaya and Hospital heggeri extension Old hubballi
Dharwad
KARNATAKA
580024
India |
| Phone |
9113072749 |
| Fax |
|
| Email |
shobhack12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinaykumar Hiremath |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital heggeri extension Old hubballi |
| Address |
Department of samhita and siddhanta
Ayurveda Mahavidyalaya and Hospital heggeri extension Old hubballi
Dharwad
KARNATAKA
580024
India |
| Phone |
9916319007 |
| Fax |
|
| Email |
dr.vinu.vrh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaykumar Hiremath |
| Designation |
Professor Department of Samhita and siddhanta |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital heggeri extension Old hubballi |
| Address |
Ayurveda Mahavidyalaya and Hospital heggeri extension Old hubballi
Dharwad
KARNATAKA
580024
India |
| Phone |
9916319007 |
| Fax |
|
| Email |
dr.vinu.vrh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya and Hospital
Heggeri extension old hubli
Hubli 580024
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Ayurveda Mahavidyalaya and hospital old hubli |
| Address |
Ayurveda Mahavidyalaya and hospital heggeri extension old hubli 580024
Karnataka
India |
| 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 shobha |
Ayurveda Mahavidyalaya and Hospital |
department of Samhita and Siddhanta
Heggeri extension old hubli
Hubli 580024
Dharwad
KARNATAKA |
9113072749
shobhack12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda Mahavidyalaya and hospital old hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G510||Bells palsy. Ayurveda Condition: ARDITAH, (2) 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: Charaka Samhita, Procedure details: Nasya with Karpasasthyadi taila for 7 days)
| | 2 | Comparator Arm | Procedure | - | shirobasti | (Procedure Reference: Charaka samhita, Procedure details: Shirobasti with Karpasasthyadi taila for 7 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with classical symptoms of Ardita
Subjects from either sex will be selected in the age group of 20-60 years
Subjects fit for Nasya Karma and Shirobasti |
|
| ExclusionCriteria |
| Details |
Subjects with more than 3 years of history of Ardita
Ardita associated with Pakshagata bilateral facial nerve paralysis intracranial hemorrhageneoplasm multiple sclerosis
Subjects with other systemic disorders which interfere with course of treatment and autoimmune disorders
Subjects with uncontrolled diabetic mellitus
Pregnant women |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptoms of ardita relieved |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
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="0"
Months="0"
Days="7" |
|
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
|
Chikista sutra
of Ardita is focusing on tarpana in the form of navana and
murdhni taila Nasya in Ardita is accepted by almost all Acharyas
where as Shirobasti is the line of treatment according to SushrutaCharaka
and Vagbhata mentions murdhini taila And Vagbhata says
amongst 4 murdhni tailas Shirobasti is the best
According to Tailaprakarana of Sahasrayoga the
phalashruti of Karpasasthyadi taila is pakshagataardita
hareth where the ingredients like Karpasasthi Bala Masha having guru
snigdha guna madhura vipaka sheeta virya are vatakapha hara and balya
in nature and ingredients like Rasna Nagara Kusta having tikta
katu rasa katu vipaka usna veerya are kapha shamaka in nature As
per chikista sutra navana and murdhni taila procedures are to be
adopted in the management of Ardita so here is A
COMPARATIVE CONCEPTO CLINICAL ANALYSIS ON ARDITE NAVANAM MURDHNI TAILAM
TARPA NAMEVA CHAAn
attempt to evaluate and compare the efficacy of single drug Karpasasthyadi
taila for both procedures will be made |