| CTRI Number |
CTRI/2025/07/090289 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of ayurvedic medicinal formulation in Facial Paralysis. |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFECT OF MASHBALADI KASHAY IN ARDITA WITH SPECIAL REFERENCE TO BELLS 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 Kiran Sanjay Dhamdhere |
| Designation |
MD,PhD(Scholar) |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) |
| Address |
A/P Talegaon Dhamdhere, Taluka- Shirur, Pune
Bharati Vidyapeeth(Deemed to be University), College of Ayurved, Bharati Educational Campus, Pune
Pune
MAHARASHTRA
412208
India |
| Phone |
7249000715 |
| Fax |
|
| Email |
kirdhamdhere1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dattatray Laxman Shinde |
| Designation |
Professor ,HOD |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) |
| Address |
Bharati Vidyapeeth(Deemed to be University), College of Ayurved, Bharati Educational Campus, Pune
Bharati Vidyapeeth(Deemed to be University), College of Ayurved, Bharati Educational Campus, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dshinde248@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dattatray Laxman Shinde |
| Designation |
Professor ,HOD |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) |
| Address |
Bharati Vidyapeeth(Deemed to be University), College of Ayurved, Bharati Educational Campus, Pune
Bharati Vidyapeeth(Deemed to be University), College of Ayurved, Bharati Educational Campus, Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dshinde248@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kiran Sanjay Dhamdhere |
| Address |
Bharati Vidyapeeth(Deemed to be University), College of Ayurved and Hospital, Bharati Educational Campus, Pune |
| 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 Kiran |
Bharati Vidyapeeth(Deemed to be University), College of Ayurved and Hospital, |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital OPD , Department of Kayachikitsa OPD no 4 , Bharati Educational Campus, Pune 411043
Pune
MAHARASHTRA |
7249000715
kirdhamdhere1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University), Pune (India) COLLEGE OF AYURVED PUNE-SATARA ROAD, PUNE-411 043, ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: ARDITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Masha Baladi Kashaya, Reference: Chakradutta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Patients having Acute onset of signs and symptoms of Ardita.(Sushrutokta Ardita)
• Facial paralysis, speech distortion,and upward rolling of eyelids, salivation with constant
pain in dental region with neck pain.
• Age group between 18 to 70 years.
• Patients will be selected irrespective of their Gender,Socioeconomic status.
• Patients who are willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
• Age group below 18 and above 70 years.
• Charakokta Ardita,Vaghabtokta Ardita (The deformities are found in the facial along with a
part of the body).
• Patient having history of Cerebrovascular Accident with Facial palsy,Head injury,Brain
tumor, cholesteatoma, schwannoma and invasive carcinoma like condition resulting in
facial palsy.
• Patient having history of Leprosy,Upper Motor Neuron Disease,Multiple Sclerosis,Viral
Infection (Herpes simplex virus,Varicella zoster virus,Epstein barr virus,Cytomegalovirus).
• Patients having Intracranial tumor,Intracranial hemorrhage,Bilateral facial palsy and
involvement of Ipsilateral or contra lateral hand and leg.
• Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in facial nerve functions in seven days. (by facial nerve
examination).
|
Base line and 7, 15 and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in facial palsy gradation by House Brackman
classification system |
base line and 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="2"
Months="1"
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
|
Acharya Charaka states that Ardita is localized in half of the face with or without involvement of half of the
body2 under context of Vatavyadhi Chikitsa Adhyaya 5.Acharya Sushrut states that this sickness only affects
the face-advised following treatment-Nasya,Dhumapana etc.Panchkarma procedures in Sushrut Samhita6
.
According to Vagbhat Ardita vyadhi is found – associated with Shopha , hence- Vamana Chikitsa advised7.
Bhavaprakasha elucidated Ardita Chikitsa according to its Types8
. Vangasena propounded chikitsa
according to Dosha Pradhanyata present in the Ardita10.As per Acharya Chakradutta-Abhyanga,Pana,
Ghritapana, Basti were explained for the management of Ardita9
. |