| CTRI Number |
CTRI/2025/02/079941 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL STUDY TO KNOW THE EFFICACY OF AN AYURVEDIC FORMULATION (SHEPHALIKA PATRA KASHYAM) FOR THE TREATMENT OF GRIDHRASI,SCIATICA |
|
Scientific Title of Study
|
A Randomised Open Label Controlled Clinical study to Evaluate the Efficacy of Shephalika Patra Kashyam in the management of 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 Riya |
| Designation |
PG Scholar |
| Affiliation |
Jammu Institute of Ayurveda and Research |
| Address |
Dept.of PGStudies in Kayachikitsa Jammu Institute of Ayurveda and Research, Kot bhalwal road Nardani Jammu and Kashmir
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
6283710238 |
| Fax |
|
| Email |
riyachandel9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Mahajan |
| Designation |
Professor |
| Affiliation |
Jammu Institute of Ayurveda and Research |
| Address |
Dept. PG Studies in Kayachikitsa, Jammu Institute of Ayurveda and Research, Kot bhalwal road Nardani, Jammu.
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9419119123 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Mahajan |
| Designation |
Professor |
| Affiliation |
Jammu Institute of Ayurveda and Research |
| Address |
Dept.of PG Studies in Kayachikitsa, Jammu Institute Of Ayurveda and Research,Kot bhalwal road, Nardani, Jammu.
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9419119123 |
| Fax |
|
| Email |
drnitinmahajan1608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu Institute Of Ayurveda and Research, Jammu 181123, India |
|
|
Primary Sponsor
|
| Name |
Jammu Institute of Ayurveda and Research Jammu |
| Address |
Kot bhalwal,Nardani, Jammu, Jammu & Kashmir 181123 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Riya |
Jammu Institute Of Ayurveda and Research, Jammu |
Room No. 102, Department of Kayachikitsa, Jammu Institute Of Ayurveda and Research,Jammu 181123, JAMMU & KASHMIR
Jammu
JAMMU & KASHMIR |
6283710238
riyachandel9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shephalika Patra Kashyam, Reference: Chakradutta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SAHACHARADI KASHYAM, Reference: ASTANGHRIDHYAM, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group of 25 – 60 years.
2.Patient representing signs and symptoms of Gridhrasi who are willing to participate in study.
3.Subjects willing to participate with written informed consent, which is conveyed in the language which the subject can understand.
4.Both males and female will be selected.
|
|
| ExclusionCriteria |
| Details |
1. Age below 25 years and above 60 years.
2. Patients suffering from Cardiac Diseases.
3. Uncontrolled Diabetes Mellitus, Hypertension.
4. Cancer of Lumbo-Sacral spine
5. Tuberculosis of vertebral column.
6. Pregnant and lactating women.
7. Patient suffering from Ankylosing spondylitis, sacroiliac arthritis, herpes simplex infection causing radiating pain, disc prolapse, degenerative changes, bony osteophytic growth.
8. Any trauma related to Lumbo-sacral spine.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters:
1.Ruk( Pain)
2.Toda( Pricking Sensation)
3. Stambha ( Stiffness)
4. Spandana ( Fasicultion)
5. Gaurva ( Heaviness)
Objective Parameters
1. X-ray Spine
2. VAS SCORE
3. Straight leg raising Test(S.L.R. Test)
4. Bragard Test.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Range of movement of lumber spine.
2) Deep tendon reflexes.
3) Gait. |
0th , 15th day, 30th day, 45th 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 3 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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 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
|
Heath is supreme foundation for the achievement of happy life. With the achievements of food habits , busy professional and sedentary life,conditions of roads, physical and mental stress which creates under pressure on spinal column and play the important role in producing low back pain. which is the most common afflictions of adults costing billions of dollars in health care resulting in more lost days of work.Ayurveda classics have given a detailed description about the treatment of vata vyadhi but detailed descriptions about the treatment of Gridhrasi is mentioned by few experts only. Gridhrasi is the most obstinate and prominent, one amongst the 80 types of Nanatmaja disorders. Gridhrasi is the painful condition in which the person can not sit and walk properly that hampers his normal activity. Ampngest all signs and symptoms of Gridhrasi resemble with the condition of sciatica as described by the modern texts. As in this disease the patients walk like the bird Gridhra and his legs become tensed and slightly curved. |