| CTRI Number |
CTRI/2025/03/083705 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [NASYA] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the combined effect of prasarini taila pratimarsha nasya and prsarini capsule in cervical radiculopathy |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study On The Combined Effect Of Prasarini Taila Pratimarsha Nasya And Prasarini Capsule In Vishwachi [Cervical Radiculopathy] |
| 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 Rakshitha J |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Department Of Kayachikitsa
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Hassan
KARNATAKA
573201
India |
| Phone |
9900744890 |
| Fax |
|
| Email |
jrachu59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakshitha J |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Department Of Kayachikitsa
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
KARNATAKA
573201
India |
| Phone |
9900744890 |
| Fax |
|
| Email |
jrachu59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasantha B |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Department Of Kayachikitsa
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Hassan
KARNATAKA
573201
India |
| Phone |
9886213224 |
| Fax |
|
| Email |
drvasantha225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital BM road Thanniruhalla Hassan 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College Of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital BM road Thanniruhalla Hassan 573201 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SDM College Of Ayurveda and Hospital |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital BM road Thanniruhalla Hassan 573201 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakshitha J |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
Department Of Kayachikitsa
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan
Hassan
KARNATAKA |
9900744890
jrachu59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M501||Cervical disc disorder with radiculopathy. Ayurveda Condition: VISVACI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Prasarini, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Bhavaprakasha , Procedure details: 2 drops BD After food)
(1) Medicine Name: Prasarini taila, Reference: Bhavaprakasha, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronicity upto 1 year.
Subjects who are fit for nasya.
Subjects irrespective of gender, caste, creed, occupation, religion and socio-economic status.
Subjects who are willing to participate and ready to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
Known cases of traumatic injury of cervical spine , cervical fractures, cervical myelopathy.
Known uncontrolled cases of diabetes mellitus and hypertension.
Impaired cardiac , renal and hepatic functions, known cases of neoplasm and infective disorders.
Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Restricted movement of neck and shoulder joint
2. Radiating pain from nape of the neck, shoulder down to the arm
3. Spurling test
4. Visual analogue scale of pain |
0th day , 11th day and 22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life WHO |
0th, 11th & 22nd day |
|
|
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 1 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="6"
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
|
The Study title is An Open Label Single Arm Clinical Study On The Combined Effect Of Prasarini Taila Pratimarsha Nasya And Prasarini Capsule In Vishwachi [Cervical Radiculopathy] which involves a total of 30 participants in the study, which includes age from 30years to 60 years and up-to 1 year chronicity and study excludes known cases of traumatic injury of cervical spine , cervical fracture , uncontrolled cases of diabetes mellitus and hypertension, and pregnant women and lactating women, assessment will be doe on 0th, 11th and 22nd day after treatment and results of the following study will be analysed and calculated by using SPSS and other suitable statistical software. |