| CTRI Number |
CTRI/2024/01/061894 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shunthyadi Payasa in gridhrasi |
|
Scientific Title of Study
|
Randomised open controlled clinical trial to evaluate the efficacy of Shunthyadi Payasa in Gridhrasi w s r to 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 Aishwarya Uday Bhosale |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9405953572 |
| Fax |
|
| Email |
aishbhosale2495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran Parshuram Wagh |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
982284610 |
| Fax |
|
| Email |
suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Uday Bhosale |
| Designation |
Pg Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9405953572 |
| Fax |
|
| Email |
aishbhosale2495@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Uday Bhosale |
| Address |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Aishwarya Uday Bhosale |
Yashwant Charitable Hospital |
OPD No 17 Kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA |
9405953572
aishbhosale2495@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi payasa , Reference: Vangasen Samhita , Route: Oral, Dosage Form: Ksheerpaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Gudika , Reference: Vangasen Samhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having signs and symptoms of Gridhrasi
Patient diagnosed with Gridhrasi
Pateint irrespective of caste income group and occupation |
|
| ExclusionCriteria |
| Details |
Spine Disorders
Known case of cancer of spine
Known case of tuberculosis of spine
Known case of congenital abnormalities in
lumbar spine
Known case of tumor of equina
Known case of trauma or injury to spine
Surgical indication in known case of fracture
Known case of diabetes mellitus
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Shunthyadi Payasa in Gridhrasi w s r to Sciatica on assessment of subjective parameters such as ruka toda stambha spandan and objective parameters such as SLR test |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses the effect of Shunthyadi Payasa in signs & symptoms of Gridhrasi such as ruka toda stambha spandan aruchi
To asses improvement by signs symptoms & gradation of assessment criteria
To study etiopathology of Gridhrasi in detail according to ayurveda text & Sciatica in detail according to modern text
To improve quality of life & reduce discomfort of patient
To achieve the outcome of study in 30 days |
30days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2024 |
| 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
|
This is randomised open controlled clinical study to evaluate the efficacy of shunthyadi payasa in gridhrasi observation will be made upon symptoms of gridhrasi study will be carried out in OPD of kayachikitsa yashwant Charitable Hospital kodoli |