| CTRI Number |
CTRI/2026/01/101034 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To Study The Effect Of Eranda Beeja Payasa And Rasanadi Guggul In The Management Of Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Eranda Beeja Payasa And Rasanadi Guggul 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 Beenish Rafiq |
| Designation |
M.D. Scholar |
| Affiliation |
Jammu Institute Of Ayurveda And Research |
| Address |
P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
6005584366 |
| Fax |
|
| Email |
beenishrafiq8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sourabh Gupta |
| Designation |
Associate Professor |
| Affiliation |
Jammu Institute Of Ayurveda And Research |
| Address |
P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
9419312498 |
| Fax |
|
| Email |
sourabh.gupta32@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Beenish Rafiq |
| Designation |
M.D Scholar |
| Affiliation |
Jammu Institute Of Ayurveda And Research |
| Address |
P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123
Jammu JAMMU & KASHMIR 181123 India |
| Phone |
6005584366 |
| Fax |
|
| Email |
beenishrafiq8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu Institute Of Ayurveda And Research , Nardni, Jammu, Jammu And Kashmir, 181123, INDIA |
|
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Primary Sponsor
|
| Name |
Jammu Institute Of Ayurveda And Research |
| Address |
Jammu Institute Of Ayurveda And Research,Nardani Bajwan,Bantalab Jammu Jammu And Kashmir, 181123 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Beenish Rafiq |
Jammu Institute Of Ayurveda And Research |
P.G. Department Of Kayachikitsa, OPD and IPD of hospital Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu, Jammu And Kashmir 181123 Jammu JAMMU & KASHMIR |
6005584366
beenishrafiq8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jammu Institute of Ayurveda & Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda Beeja Payas, Reference: Bhaishajya Ratnavali By chaukambha sanskrit sansthan vidhyotini tikska vata vyadhi Gridhrasi chikitsa shlok no 42, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Follow up :- on 15th day, 30th day and 45th day
-Drug free Follow up :- on 45th day
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasana Guggul vati, Reference: Yogaratnakara with Vidyotini hindi commentary by Vd. Laksmipati Shastri edited by Brahmasankar www.wjpls.org│Vol 9, Issue 4, 2023.│World Journal of Pharmaceutical and Life Science Shastri; pub. by Chaukhambha Sanskrit Sansthan, Varanasi; Uttarardh, chapter Vata Vyadhi chikitsa page no 523 shloka no 1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Follow up :- on 15th day, 30th day and 45th day
-Drug free Follow up :- on 45th day
|
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective and objective parameters of Gridhrasi (Sciatica) :
SUBJECTIVE CRITERIA -
TODA,RUK, STAMBHA, SPANDANA, GAURAVA, ARUCHI, TANDRA
OBJECTIVE CRITERIA -
VAS SCORE, SLR TEST, BRAGARD’S TEST
|
Assessment : Percentage relief in symptoms and signs after 30 days of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Functional Mobility
2.Reduction in Associated Symptoms
3.Enhancement in Quality of Daily Activities
|
After successful completion of treatment on 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 2 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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 randomized, open-label, comparative clinical study evaluates the efficacy of Eranda Beeja Payas in the management of Gridhrasi (sciatica) in comparison with Rasanadi Guggul, based on Ayurvedic principles. Gridhrasi, described in classical texts as a Vata Vyadhi presenting with Stambha, Ruk, Toda, and Spandana, closely parallels modern sciatica caused by compression or irritation of the sciatic nerve. Considering the limitations of contemporary treatments and the high prevalence of low back pain and sciatica, this study aims to explore an effective, non-invasive Ayurvedic intervention.
A total of 30 patients (aged 25–60 years) meeting diagnostic criteria of Gridhrasi will be randomly allocated into two groups of 15 each. Group A will receive Eranda Beeja Payas prepared as per classical guidelines, with dosage tailored to the patient’s Agni for 30 days. Group B will receive Rasanadi Guggul (500 mg BD). Follow-ups will occur on Day 15, 30, and 45, including drug-free follow-up on Day 45. Assessment will be based on both subjective parameters (Toda, Ruk, Stambha, Spandana, Gaurava, Aruchi, Tandra) and objective parameters (VAS score, SLR test, Bragard’s test). Data will be statistically analyzed to determine comparative therapeutic efficacy.
The primary objective is to assess whether Eranda Beeja Payas offers significant improvement in symptoms of Gridhrasi relative to Rasanadi Guggul. Results will contribute to evidence-based validation of classical Ayurvedic formulations used in Vata-Vyadhi management. |