| CTRI Number |
CTRI/2025/07/091430 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of sciatica through ayurveda |
|
Scientific Title of Study
|
Evaluation of efficacy of vishwadi guggulu and kala basti in comparision to conventional management (pregabalin and physiotherapy) in cases of gridhrasi(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 Raksha gupta |
| Designation |
MD scholar |
| Affiliation |
pt khusilal sharma govt autonomous ayurveda college and institute bhopal mp |
| Address |
Pg department of kayachikitsa pt khusilal sharma govt autonomous ayurveda college and institute bhopal mp
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9893347805 |
| Fax |
|
| Email |
guptaraksha1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek sharma |
| Designation |
Reader |
| Affiliation |
pt khusilal sharma govt autonomous ayurveda college and institute bhopal mp |
| Address |
Pg department of kayachikitsa pt khusilal sharma govt autonomous ayurveda college and institute bhopal mp
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827937247 |
| Fax |
|
| Email |
drvivek.sharma13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAKSHA GUPTA |
| Designation |
MD SCHOLAR |
| Affiliation |
Pt khusilal sharma govt autonomous ayurveda college and institute bhopal mp |
| Address |
Pg department of kayachikitsa pt khusilal sharma govt autonomous ayurveda college and institute bhopal mp
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9893347805 |
| Fax |
|
| Email |
guptaraksha1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt khusilal sharma govt autonomous ayurved college and institute bhopal mp 462003 |
|
|
Primary Sponsor
|
| Name |
Dr Raksha Gupta |
| Address |
Pg department of kayachikitsa pt khushilal sharma government autonomous ayurved college and institute bhopal madhya pradesh |
| Type of Sponsor |
Government funding agency |
|
|
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 Raksha Gupta |
Pt khushilal sharma government autonomous ayurved college and institute bhopal mp |
Room no 221
Pt khushilal sharma government autonomous ayurved college and institute bhopal mp
Bhopal
MADHYA PRADESH |
9893347805
guptaraksha1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt khushilal sharma government autonomous ayurved college and institute bhopal madhya pradesh |
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 | Drug | Classical | | (1) Medicine Name: Vishwadi guggulu, Reference: Bharat bhaisajya ratnakar fourth volumeslok no.6692, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: | | 2 | Intervention Arm | Procedure | - | kAla-bastiH, काल-बस्तिः | (Procedure Reference: Charak siddhi sthan, Procedure details: Purvakarma- Srvang abhyang swedan will be done
Pradhan karma-Ptient will lie in left lateral position bending the left knee.then basti (anuvasan)will be administered)
(1) Medicine Name: Shwadamstra tailam, Reference: Bharat bhaisajya ratnakar fifth volume Slok no.6730, Route: Rectal, Dosage Form: Taila, Dose: 90(ml), Frequency: od, Duration: 10 Days | | 3 | Intervention Arm | Procedure | - | kAla-bastiH, काल-बस्तिः | (Procedure Reference: Charak samhita siddhi sthan, Procedure details: Purvakarma- Srvang abhyang swedan will be done Pradhankarma- Ptient will lie in left lateral position bending the left knee. Then basti (Niruha)will be administered)
(1) Medicine Name: Vrushadi kwath, Reference: susuruta samhita chikitsa sthan chapter 38 Sloka 67-70, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 360(ml), Frequency: od, Duration: 6 Days | | 4 | Comparator Arm (Non Ayurveda) | | - | pregabalin | Pregabalin tablet is used for the management of neuropathic pain assosciated with spinal cord injury | | 5 | Comparator Arm (Non Ayurveda) | | - | physiotherapy | Ultra sound therapy(UFT) is a physical therapy treatment that uses high frequency soundc waves to trat pain and healing in soft injuries for 6 minutes
Interferential therapy(IFT) is a type of electro therapyto relieve pain reduce inflammation and promote healing for 10 minutes |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Duration of illness upto 2 years
Radiating pain starting from the gluteal region towards the foot
Tenderness over the sciatic nerve course
Severe pain on squatting Sensory changes
Non involvement of urinary bladder and rectum
Positive straigh leg raising sign |
|
| ExclusionCriteria |
| Details |
Paraplegia Hip joint arthiritis TB spine hip Pelvic pathology Traumatic lesion in lumbosacral region
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of study scholar will be able to evaluate the efficacy Of vishwadi gugglu with kala basti in management of gridhrasi (Sciatica)
|
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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
|
It is expected that at the end of study, scholar will be able to evaluate the efficacy Of vishwadi gugglu with kala basti in management of gridhrasi (Sciatica) |