| CTRI Number |
CTRI/2025/02/080719 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA)
Other (Specify) [External Panchakarma Procedure] |
| Study Design |
Other |
|
Public Title of Study
|
A Comparitive Study Between Two External Procedures, Nirgundi Patra Pinda Sweda And TENS Machine In Sciatica. |
|
Scientific Title of Study
|
A Comparative Study Of Nirgundi Patra Pinda Sweda And Transcutaneous Electrical Nerve Stimulation In Gridhrasi With Special Reference 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 Aboli Vijayrao Keche |
| Designation |
M.D. Scholar Panchakarma Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik |
| Address |
Panchakarma OPD, Ground Floor, Department Of Panchakarma, Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik, Maharashtra, India
Pincode- 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
7709735563 |
| Fax |
|
| Email |
aboli317keche@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Shivaji Phadol |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik |
| Address |
Panchakarma OPD, Ground Floor, Department Of Panchakarma, Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik, Maharashtra, India, Pin Code-422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9975641619 |
| Fax |
|
| Email |
ravindrasphadol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Shivaji Phadol |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik |
| Address |
Panchakarma OPD, Ground Floor, Department Of Panchakarma, Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal nagar , Hirawadi, Panchavati, Nashik, Maharashtra, India, Pin code - 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9975641619 |
| Fax |
|
| Email |
ravindrasphadol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal Nagar, Hirawadi, panchavati,Nashik, Maharashtra, India, Pin code - 422003 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal Nagar, Hirawadi, Panchavati, Nashik, Maharashtra, India, Pin code - 422003 |
| Type of Sponsor |
Other [Private Ayurved 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 Aboli Vijayrao Keche |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
Panchakarma OPD, Ground Floor, Department Of Panchakarma, Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Kamal Nagar, Hirawadi,Panchavati, Nashik, Maharashtra, India, Pin code- 422003
Nashik
MAHARASHTRA |
7709735563
aboli317keche@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya and Hospital, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Charak sutrasthan 14/41, Ashtanghriday sutrasthan 17/06, Procedure details: PURVAKARMA
Aatursiddhata- Patients will be selected as per inclusive criteria & will be duly prepared.
Aushadhasiddhata
• Fresh Nirgundi leaves (500 gm)
• Saindhav lavana (10 gm)
• Murchita Tila tail (20 ml)
UpakaranSiddhata Abhyanga Table, Vessels having round bottom,
Spoon, Handle, Plate, Gas cylinder, Stove, Knife,
Napkin, Cotton cloth – 2 (approx. 18 inches square
cloth), Threads – 2 (5 feet long cotton threads).
PRADHANKARMA
Name of Procedure
By giving prone position to patient, prepared pottali
will be administered in circular & linear manner.
Position of Patient- Prone position
Administration-Tapping, Pressing, Squeezing pottali
Route of Administration -External
PASCHAT KARMA Sponging
Duration 20 min, daily for 7 days.)
| | 2 | Intervention Arm | Procedure | - | Transcutaneous Electrical Nerve Stimulation | (Procedure Reference: , Procedure details: 1)Instruments required- TENS machine, Paper Sticking, Sterile Cotton
swab.
2)By giving prone position to patient, two pairs of electrodes are placed
on the either side of pain full areas.
3) Frequency of 2 Hz, 40 Hz, 80 Hz, 130 Hz, changes with time
And Sweep mode will be applied.
4) Duration- 20 min daily for 7 days
5) After complete procedure remove sticking followed by removing
electrodes. Wipe out gel with cotton.
Time- Once a day in morning (In between 9am to 12pm)
Follow up- On 7th & 14th day (AT))
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Presence of Ruka, Stambha in the sphika and Symptoms of Gridhrasi.
2) Patients indicated for Patra pinda sweda and TENS.
3) Age : 21 to 60 years
4) Gender : Male and Female Both |
|
| ExclusionCriteria |
| Details |
1) Patient having congenital Structural Deformities.
2) Patient having pacemaker, implant, fracture and needs surgical care
will be excluded.
3) Gridhrasi associated with Paralysis, RA, Post operative cases(within 2
month after surgery),etc.
4) Patient unfit for swedana and TENS.
5) Age below 21 years and above 60 years. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Sign and Symptoms Of Gridhrasi |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of Gridhrasi |
14 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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="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
|
Aim / Primary Objective
To compare the effect of Nirgundi Patra Pinda Sweda And Transcutaneous Electrical Nerve Stimulation In Gridhrasi with specific focus on Radiating pain.
Secondary Objective 1) To study the Gridhrasi according to Ayurveda and Modern science. 2) To study concept of Swedana karma through Ayurvedic literature and Transcutaneous Electrical Nerve Stimulation through physiotherapy literature. 3) To compare the improvement in functional outcomes, including mobility between the two treatment modalities.
PARTICIPANTS 60 Adults diagnosed with Gridhrasi, meeting inclusion and exclusion criteria from OPD and IPD of department of Panchakarma, Shree Saptashrungi Mahavidyalaya and Hospital Nashik Interventions Group A – Nirgundi patra pinda sweda for 7 days Group B – TENS for 7 days Follow up – On 7th & 14th day
Primary Outcome : Reduce the sign and symptoms of Gridhrasi
Secondary Outcome: No Recurrence of Gridhrasi. Treatment Duration : 7 Days
ASSESMENT :0th , 7th , 14th Days |