| CTRI Number |
CTRI/2025/08/092796 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Evaluate The Efficacy Of Brihat Panchmooli Niruha Basti and Erandmooladi Niruha Basti In Gridhrasi Sciatica |
|
Scientific Title of Study
|
An open label comparative randomized controlled trail to evaluate the efficacy of brihat panchmooli niruha basti and erandmooladi niruha basti in 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 Kajal Gupta |
| Designation |
MD Panchkarma Scholar |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 69 1st Floor Institute For Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7006176835 |
| Fax |
|
| Email |
mhjnkajal123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Rana |
| Designation |
Assistant Prof PG Department of Panchkarma |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 69 1st Floor Institute For Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9896262681 |
| Fax |
|
| Email |
mamtaranakhatri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Gupta |
| Designation |
MD Panchkarma Scholar |
| Affiliation |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Room no 69 1st Floor Institute For Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
7006176835 |
| Fax |
|
| Email |
mhjnkajal123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for ayurved studies and research Shri krishana AYUSH university kurukshetra haryana
136118 india |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies And Research Shri Krishana AYUSH University |
| Address |
Sector 8 Umri road kurukshetra 136118 Haryana India |
| Type of Sponsor |
Government medical 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 Kajal Gupta |
Institute for ayurved studies and research Shri krishana AYUSH university kurukshetra haryana |
Room no 69 1st Floor Institute For Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA |
7006176835
mhjnkajal123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAU KURUKSHETRA, IEC (INSTITUITONAL ETHICS COMMITTEE) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brihat Panchmooli, Reference: Chakkardatt, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 960(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Erandamooladi, Reference: Charakasiddhi, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 960(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign the consent form
Patients between the age group of 30 to 50 years of either sex
Patients presenting with clinical features of Gridhrasi Vataj and Vatakaphaj
Patient showing a positive SLR test result up to 60 degree of leg elevation
Patients with chronicity of disease less than 3 years
Patients fit for Basti Karma BastiYogya |
|
| ExclusionCriteria |
| Details |
Subjects with chronicity of disease more than 3 years
Subjects of either sex age below 30 years and above 50years
The patients unfit for Basti Karma Basti Ayogya
Patients having systemic pathologies already diagnosed which interfere with intervention will be excluded
Patient having tuberculosis of spine spinal tumors vertebral fractures surgical conditions
hyperuricemia and auto immune disease like rheumatoid arthritis ankylosing spondylitis
already diagnosed
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment in reduction in Ruka pain Intensity by using VAS SCALE |
4 week 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms Such as Stambha Stiffness Supata Numbness Aruchi Anorexia Tandra (Drowsiness), Gaurav (Heaviness). |
4 weeks 4 days |
|
|
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
|
N/A |
|
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="6"
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
|
Gridhrasi displays characteristics of modern-day Sciatica Gridhrasi is evident from the name that the condition not only causes pain but also makes it difficult for patients to walk, which is extremely irritating to them. The patient’s gate is a representation of a Gridhra vulture due to their severe suffering. Despite the disease’s presence in the leg it interferes with the patients everyday activities and quality of life The primary symptoms of Gridhrasi include pain Ruka stiffness Stambha pricking sensation Toda and twitching Muhurspandana in the Sphika Kati Uru Janu Jangha and Pada respectively
|