| CTRI Number |
CTRI/2025/03/083740 [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) [MATRA BASTI] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the combined effect of Prasarini capsule and Prasarini taila matra basti in sciatica . |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study to Evaluate the Combined Effect of Prasarini Capsule and Prasarini taila Matra Basti in Gridrasi(Sciatica) |
| 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.Shweta sajjan |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan Karnataka 573201 |
| Address |
SRI DHARMASTHALA MANJUNATHESWARA
COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA.573201
SRI DHARMASTHALA MANJUNATHESWARA
COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA.573201
Hassan
KARNATAKA
573201
India |
| Phone |
8073230458 |
| Fax |
|
| Email |
Shwetav.sajjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.Shweta Sajjan |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Hassan Karnataka 573201 |
| Address |
SRI DHARMASTHALA MANJUNATHESWARA
COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA.573201
SRI DHARMASTHALA MANJUNATHESWARA
COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA.573201
Hassan
KARNATAKA
573201
India |
| Phone |
8073230458 |
| Fax |
|
| Email |
Shwetav.sajjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Muttappa Totad |
| Designation |
Professor |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA.573201 |
| Address |
SRI DHARMASTHALA MANJUNATHESWARA
COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA.573201
SRI DHARMASTHALA MANJUNATHESWARA
COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA.573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886924949 |
| Fax |
|
| Email |
totadmv225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara College Of Ayurvedic and Hospital Hassan Karnataka 573201 |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Sri Dharmasthala Manjunatheswara College Of Ayurvedic and Hospital Hassan Karnataka 573201 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Dharmasthala Manjunatheswara College Of Ayurvedic and Hospital Hassan Karnataka |
Department Of Kayachikitsa
Sri Dharmasthala Manjunatheswara College Of Ayurvedic and Hospital Hassan Karnataka 573201. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRSHWETA SAJJAN |
SDM Ayurvedic Medical College And Hospital |
DEPARTMENT OF KAYACHIKITSA SRI DHARMASTHALA MANJUNATHESWARA
COLLEGE OF AYURVEDA AND HOSPITAL HASSAN KARNATAKA
573201
Hassan
KARNATAKA |
8073230458
Shwetav.sajjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheswara Ayurvedic Medical College And Hospital Hassan Karnataka.573201 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PRASARINI CAPSULE, Reference: AYURVEDIC PHARMACOPEIA OF INDIA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 24 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: - | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: BHAVAPRAKSHA MADHYAMA KHNADA, Procedure details: 70ML MORNING AFTER FOOD THROUGH RECTAL FOR 8 DAYS )
(1) Medicine Name: PRASARINI TAILA, Reference: BHAVAPRAKASHA, Route: Rectal, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronicity less than 1 year
Patient fit for Basti
Subjects Who Are Willing To Participate And Sign The Informed Consent Form. |
|
| ExclusionCriteria |
| Details |
DIAGNOSED CASE OF DESIEASE OF SPINE TB OF SPINE NEOPLASM OF SPINE SPINE FRACTURE AND INFECTIONS
IMPAIRED CARDIAC AND HEPATIC AND RENAL FUNCTIONS
UNCONTROLLED DIABETIC MELLITUS (HBA1C MORE THAN 8)
AND HYPERTENSION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ruk(pain)
Toda
Stambana
Straight Leg Raise Test |
1ST DAY, 9TH DAY AND 25TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life (WHO) |
1ST DAY, 9th DAY AND 25th 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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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 to Evaluate the Combined Effect of Prasarini Capsule and Prasarini taila Matra Basti in Gridrasi(sciatica)which involves total number of 30 patients in the study which includes age from 30 to 60 years and chronicity less than 1 year and study excludes diagnosed case of diseases of spine tb of spine neoplasm of spine, spine fracture,infections and impaired cardiac and hepatic and renal functions and uncontrolled diabetes mellitus(more than 8) and uncontrolled hypertension assessment will be done on 1ST DAY, 9TH DAY AND 25TH DAY after treatment results of the following study will be analysed and calculated by using spss and other suitable statistical software |