| CTRI Number |
CTRI/2025/08/093188 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the added effect of Erandataila alongwith Panchamooli Kashaya in the Pain management of Gridhrasi ( Sciatica ) through a Comparative clinical study. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the added effect of Erandataila with Panchamooli Kashaya in the pain management of Gridhrasi vis-a-vis 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 Jeenu Ann Benny |
| Designation |
PG Scholar |
| Affiliation |
Ramakrishna Ayurvedic Medical College,Hospital And Research Centre |
| Address |
Department of Kayachikitsa In PG Studies,Ramakrishna Ayurvedic Medical College,Hospital And Research Centre,54/2,Ramagondanahalli,Yelahanka,Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
8281656425 |
| Fax |
|
| Email |
jeenubenny17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana C P |
| Designation |
Professor,HOD |
| Affiliation |
Ramakrishna Ayurvedic Medical College,Hospital And Research Centre |
| Address |
Department of Kayachikitsa In PG Studies,Ramakrishna Ayurvedic Medical College,Hospital And Research Centre,54/2,Ramagondanahalli,Yelahanka,Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9900063059 |
| Fax |
|
| Email |
aayurvedalaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana C P |
| Designation |
Professor,HOD |
| Affiliation |
Ramakrishna Ayurvedic Medical College,Hospital And Research Centre |
| Address |
Department of Kayachikitsa In PG Studies,Ramakrishna Ayurvedic Medical College,Hospital And Research Centre,54/2,Ramagondanahalli,Yelahanka,Bangalore.
KARNATAKA
560064
India |
| Phone |
9900063059 |
| Fax |
|
| Email |
aayurvedalaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| RamaKrishna Ayurvedic Medical College,Hospital And Research Centre,54/2,Ramagondanahalli,Yelahanka,Bangalore-560064 |
|
|
Primary Sponsor
|
| Name |
Dr Jeenu Ann Benny |
| Address |
Department of Kayachikitsa in PG Studies,RamaKrishna Ayurvedic Medical College,Hospital And Research Centre,54/2,Ramagondanahalli,Yelahanka,Bangalore-560064 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jeenu Ann Benny |
RamaKrishna Ayurvedic Medical College ,Hospital And Research Centre |
Department of PG Studies , Kayachikitsa Department.
54/2,Ramagondanahalli,Yelahanka,Bangalore-560064
Bangalore
KARNATAKA |
8281656425
jeenubenny17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RamaKrishna Ayurvedic Medical College,Hospital And Research Centre Ethical Clearence Committee |
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: Panchmooli Kashaya, Reference: Bhisagratna , Brahmasankar Sastri ,editor Vidyotini Hindi Commentary by Vaidya Laksmipati Sastri ,Yogaratnakara , Chaukambha Prakashan , Varanasi , Reprint edition , 2007 , verse no 1 ,pg no 521-522Bhisagratna , Brahmasankar Sastri ,editor Vidyotini Hindi Commentary by Vaidya Laksmipati Sastri ,Yogaratnakara , Chaukambha Prakashan , Varanasi , Reprint edition , 2007 , verse no 1 ,pg no 521-522, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: 3 g Trivrit Choorna), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchamooli Kashaya, Reference: Sri Vaidhya Sankaralalaji Jain,editor, Kavivar Sri Shaligramaji Vaishya,Commentator ,Vangasena Hindi Tikka Samhita ,Vatavyadhi Adhikara, verse no 582, Khemaraj Srikrishnadas Prakashan, Mumbai, 2003, pg 373 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: 3 g Trivrit Choorna with 2.5 ml Eranda Taila), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are ready to participate and sign the informed consent form
Patients of age group between 20 to 60 years of age irrespective of gender, religion and occupation will be selected.
Patients presenting with Lakshanas of Gridhrasi.
|
|
| ExclusionCriteria |
| Details |
• Congenital deformity of spine
• Subjects with history of spinal fracture, Neoplastic condition and Dislocation of
Spine
• Infective conditions of spine
• Fractures of pelvis and femur
• Uncontrolled Diabetes , Uncontrolled Hypertension
• Pregnant woman and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Relief |
0th day, 7th day, 15th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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="1"
Days="15" |
|
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 clinical trial is a comparative clinical study done in Gridhrasi patients in 2 groups- Group A -Panchamooli kashaya with Trivrit churna and Group B - Panchamooli kashaya with Trivrit churna and Erandataila for 15 days. Main outcome expected in this trial is the reduction in Lowback pain. |