| CTRI Number |
CTRI/2025/08/093393 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to assess improvement in brain function and physical coordination in patients with thrombotic stroke using Jatamansi oil nasal drops, Jatamansi oil aroma therapy, Lavender oil aroma therapy, and standard treatment |
|
Scientific Title of Study
|
Evaluation of Psychomotor and Cognitive Functions in patients of Chronic Thrombotic Stroke by Four Armed Parallel Study(Jatamansi Oil Nasya 1 percent Jatamansi Oil Aromatherapy Lavender Oil Aromatherapy and Standard Care) |
| 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 Apoorva Shyamsunder Pande |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and research centre Salod |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and research centre Salod
Wardha
Maharashta
Wardha
MAHARASHTRA
4420001
India |
| Phone |
8208210373 |
| Fax |
|
| Email |
apoorvaspande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apoorva Shyamsunder Pande |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and research centre Salod |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and research centre Salod
Wardha
Maharashta
Wardha
MAHARASHTRA
4420001
India |
| Phone |
8208210373 |
| Fax |
|
| Email |
apoorvaspande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and research centre Salod |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi
Ayurved College Hospital and research center salod
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
4420001
India |
| Phone |
9860667023 |
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra India 442001
|
| 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 Apoorva Shyamsunder Pande |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no 40
Department of
Panchakarma Mahatma
Gandhi Ayurved
College Hospital and
Research Centre Salod
Hirapur Wardha
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
8208210373
apoorvaspande@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Standard Care | Pentoxifylline,Aspirin | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: अ.सं.सु 39/3, Procedure details: nasya with jatamansi taila pratimarsha 2 2 drops in both nostrils,Frequency od,Route Nasal,Form-Taila,Duration -21 days)
(1) Medicine Name: jatamansi, Reference: nibandha sangraha, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 21 Days | | 3 | Intervention Arm | Procedure | - | aromatherapy | (Procedure Reference: Effect of aromatherapy with lavender 10% essential oil on motor function, speech and delirium in patients with acute thrombotic cerebral ischemia. Caspian Journal of Neurological Sciences. 2019 Apr 10;5(2):49-55. , Procedure details: 2 drops on cotton by inhalation method)
(1) Medicine Name: jatamansi essential oil, Reference: Charak chikitsa 28/32, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 21 Days | | 4 | Comparator Arm (Non Ayurveda) | | - | Aromatherapy | Aromatherapy with 10% Lavender Essential Oil 2 drops on cotton then inhalation once a day |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Afore said patients who are willing to give written Informed Consent & Abide Instructions .
Patients of either Gender having Age group Between 19-70 years and diagnosed with Thrombotic Cerebrovascular stroke through MRI Brain.
Patients fit for Nasya , Aromatherapy and Thrombolytic therapy.
No history of cognitive/psychiatric medication, no alcohol dependence,no history of lengthy surgeries and willingness to take part.
|
|
| ExclusionCriteria |
| Details |
Patient with Hemorrhagic Stroke.
Patients having Cardiac Disease like Myocardial Infarction Angina etcetra
Patients having Diabetic-Neuropathy Retinopathy Pregnant and Lactating women
Patient with Acute complication like Cirrhosis of liver Pancreatitis and Hypoglycemic shock
Patients having uncontrolled Hypertension [Systolic Blood Pressure greater than or equal to 140 and Diastolic Blood Pressure greater than or equal to 90mmHg] and uncontrolled Diabetes Mellitus[Fasting Blood Sugar greater than 130mgdl Post Prandial Blood Sugar greater than 180 mgdl].
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation and comparison of Psychomotor and Cognitive Functions in Patients of Chronic Thrombotic Stroke by Four Armed Parallel Study(Jatamansi Oil Nasya
1 percent Jatamansi Oil Aromatherapy Lavender Oil Aromatherapy and Standard Care) |
at baseline 42 day 63 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate Psychomotor and Cognitive Functions in patients of Chronic Thrombotic Stroke by Four Armed Parallel Study(Jatamansi Oil Nasya ,1%Jatamansi Oil Aromatherapy, Lavender Oil Aromatherapy and Standard Care) |
at baseline 6 weeks 9 weeks |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
17/09/2025 |
| 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="0"
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
|
The volunteers will be informed about the study protocol Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated Prior to the study approval will be taken from IEC MGACHRC Salod (H) Wardha and CTRI registration will be done After selection each participant will be tested individually and selected according to selection criteria They are divided into four groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial It will include a 21 days treatment period and at Day follow up period 0th 42 nd and 63rd day |