| CTRI Number |
CTRI/2025/02/081351 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of internal administration of Nirgundi eranda taila in comparison to Gandharvahasthadhi eranda taila in the management of low back pain |
|
Scientific Title of Study
|
Effect of samana snehapana with Nirgundi eranda taila in comparison to Gandharvahasthadhi eranda taila in the management of low back pain |
| 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 Lisna Sherin K E |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Panchakarma
Government Ayurveda College Thiruvananthapuram
Government Ayurveda Panchakarma Hospital Poojappura Kerala
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9562008068 |
| Fax |
|
| Email |
lisnasherin68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lisna Sherin K E |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Panchakarma
Government Ayurveda College Thiruvananthapuram
Government Ayurveda Panchakarma Hospital Poojappura Kerala
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9562008068 |
| Fax |
|
| Email |
lisnasherin68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju P S |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram
Government Ayurveda Panchakarma Hospital Poojappura kerala
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9847317295 |
| Fax |
|
| Email |
manjumahesh1977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Lisna Sherin K E |
| Address |
Department of Panchakarma
Government Ayurveda College
Thiruvananthapuram
Government Ayurveda Panchakarma Hospital Poojappura kerala 695012
|
| 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 Lisna Sherin K E |
Government Ayurveda Panchakarma Hospital |
Department of Panchakarma
Government Ayurveda College Thiruvananthapuram
Government Ayurveda Panchakarma Hospital OP NO :1Poojappura Kerala
Thiruvananthapuram
KERALA |
9562008068
lisnasherin68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC)Govt Ayurveda college Thiruvananthapuram Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | AByantarasnehaH , आभ्यन्तर स्नेहः | (Procedure Reference: Ashtanga hridaya sutrasthana 16 th chapter , Procedure details: Gandharvahasthadhi kashaya & shaddharana choorna are using for deepana & pachana.The procedure is to be done in empty stomach when the previous food got digested & the participants having the feeling of hunger.On the first day hraseeyasi matra( 5ml/10ml)of Gandharvahasthadhi eranda taila based on Agni & Koshta is given.
The time taken for the digestion of the sneha is noted.Based on that dose, six hour digestion to be calculated & it is continued for 14 days.)
| | 2 | Intervention Arm | Procedure | - | AByantarasnehaH , आभ्यन्तर स्नेहः | (Procedure Reference: Ashtanga hridaya sutrasthana 16 th chapter , Procedure details: Gandharvahasthadhi kashaya & shaddharana choorna is using for deepana & pachana.The procedure is to be done in empty stomach when the previous food got digested & the participants having the feeling of hunger.On the first day hraseeyasi matra( 5ml/10ml)of Nirgundi eranda taila based on Agni & Koshta is given.Reference of Nirgundi eranda taila is chikitsa Manjari vatavyadhi adhyaya.
The time taken for the digestion of the sneha is noted.Based on that dose, six hour digestion to be calculated & it is continued for 14 days.)
|
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of age group 20-60 years
Participants with mechanical low back pain diagnosed as per X ray of lumbosacral spine
Participants who are indicated for snehapana |
|
| ExclusionCriteria |
| Details |
Injury to spine
Dislocation of vertebrae
Deformities and congenital defects
Spondylolisthesis
Tuberculosis of spine
Suspected neoplasm of spine
Lowback pain associated with systemic illness
Participants with uncontrolled hypertension,diabetes mellitus
Severe renal and liver disorder
Low backpain associated with infection like osteomyelitis,septic discitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome measures are evaluated by comparing the pre and post measurments in VAS scale,oswestry disability questionnaire and Quebec back pain disability scale |
0th day,6th day,22nd day,36th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2025 |
| 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
|
Low back pain is usually non-specific or mechanical .Mechanical low backpain arises intrinsically from the spine,intervertebral disc or surrounding soft tissues. Due to similar presentations Low back pain can be correlated with Kateegraha mentioned in our classics.In kateegraha as vata is predominantly vitiated ,snehana is one of the effective treatment to treat the vitiated vata.Among the snehana therapy,samana snehapana could be very effective treatment modality.Nirgundi eranda taila is mentioned in chikitsa manjari vatavyadhi adhyaya has a direct effect on vitiated vata at katee pradesha.The objectives of this studies to compare the effect of samana snehapana with Nirgundi eranda taila in comparison with Gandharvahasthadi eranda taila in the management of low backpain.The study is comparative clinical trial with control group.Participants of age group 20-60 years registered in OPD of Government Ayurveda College Panchakarma Hospital, Thiruvananthapuram having low back pain satisfying the inclusion criteria will be selected. Data will be collected using clinical case proforma.Assessment will be done using Visual analogue scale,Oswestry disability questionnaire and Quebec backpain disability scale. A total of 30 participants will be selected for the study. They will be subjected to consecutive sampling,divided into two groups( Group A and Group B).In Group A Nirgundi eranda taila as samana snehapana will be given for 15 days and Group B Gandharva hasthadhi eranda taila as samana snehapana will be given for15 days.Both the groups will be assessed before and after the intervention on 0th day,6th day, after the treatment on 22nd day, follow up on 36th day.The result will be analysed statistically by using paired t test and Wilcoxon’s signed rank test. |