| CTRI Number |
CTRI/2025/03/081930 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Raktamokshana Agnikarma and Marma Chikitsa in the management of Gridhrasi |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Raktamokshana Agnikarma and Marma Chikitsa in the management of Gridhrasi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anil Kumar Sharma |
| Designation |
Professor |
| Affiliation |
RGGPG Ayurvedic college and hospital Paprola. |
| Address |
Room no 207 of Shalya Tantra Department Anatomy block of
RGGPG Ayurvedic College and Hospital Paprola VPO Paprola
Teh Baijnath Distt Kangra Himachal Pradesh 176115
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
|
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Kumar Sharma |
| Designation |
Professor |
| Affiliation |
RGGPG Ayurvedic college and hospital Paprola. |
| Address |
Room no 207 of Shalya Tantra Department Anatomy block of
RGGPG Ayurvedic College and Hospital Paprola VPO Paprola
Teh Baijnath Distt Kangra Himachal Pradesh 176115
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
|
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Kumar |
| Designation |
PG SCHOLAR |
| Affiliation |
RGGPG Ayurvedic college and hospital Paprola Distt Kangra |
| Address |
Room no.207 Deptt of Shalya Tantra RGGPG Ayurvedic college and hospital Paprola Teh Baijnath Distt
Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018385649 |
| Fax |
|
| Email |
vivek301082@gmail.com |
|
|
Source of Monetary or Material Support
|
| RGGPG Ayurvedic College Paprola, Distt. Kangra Pincode 176115 Himachal Pradesh INDIA |
|
|
Primary Sponsor
|
| Name |
Principal RGGPGAyurvedic college and hospital Paprola |
| Address |
R.G.G.P.G.Ayurvedic college and hospital Paprola Teh Baijnath Distt
Kangra Himachal Pradesh 176115 |
| 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 Anil Kumar Sharma |
R.G.G.P.G.Ayurvedic college and hospital Paprola H.P. |
OPD/IPD of Shalya
Tantra Department
R.G.G.P.G.Ayurvedic
College and Hospital
Paprola Teh Baijnath
Distt Kangra
H.P.176115
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9805056393
dranilpaprola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NSTITUTIONAL ETHICAL COMMITTEE HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G541||Lumbosacral plexus disorders, (2) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (3) ICD-10 Condition: G541||Lumbosacral plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnikarma |
Agnikarma will be done between kandra and gulpha at most tender point Vidhagnikarma will be done
Four sittings at interval of 1 week for 4 weeks |
| Intervention |
Marma Chikitsa |
Four sittings at interval of 1 week for 4 weeks |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Raktamokshana |
Raktamokshana should be done 4 angula either above or below the janusandhi
Four sittings at interval of 1 week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Gridhrasi with symptoms like Ruja, Stambha, Suptata, Spandana, Tandra, Gaurav, Arochak
Signs like Sakthinikshepa nigraha (SLR, i.e., straight leg rising test positive)
Patients of age group between 18 and 70 years
|
|
| ExclusionCriteria |
| Details |
Tuberculosis of spine and hip joint, malignancy of spine or other organs
Old bony injuries related to spine
Cardiac diseases (ischemic heart disease, coronary artery disease, myocardial infarction etc.)
Anemia, Bleeding disorders
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Raktamokshana , Agni Karma and Marma Chikitsa in the management of patients of Gridhrasi. |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Explore Ayurvedic text pertaining to Gridhrasi.
|
6 Weeks |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="0"
Months="1"
Days="12" |
|
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
|
|