| CTRI Number |
CTRI/2023/06/054392 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
23/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Raktamokshana & Marma Chikitsa with Aabhadi churna in Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A comparative clinical study of Raktamokshana & Marma Chikitsa with Aabhadi churna 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 Vimal Kumar |
| Designation |
Associate Professor |
| Affiliation |
Uttarakhand Ayurved University Rishikul Campus Haridwar |
| Address |
OPD NO.7 Department of Shalya Tantra,Rishikul Ayurved Hospital, Rishikul Campus,Uttarakhand Ayurved University, Haridwar 249401 Uttarakhand India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9415812272 |
| Fax |
|
| Email |
imsvimal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Kumar |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurved University Rishikul Campus Haridwar |
| Address |
OPD NO.7 Department of Shalya Tantra,Rishikul Ayurved Hospital, Rishikul Campus,Uttarakhand Ayurved University, Haridwar 249401 Uttarakhand India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9415812272 |
| Fax |
|
| Email |
imsvimal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himani |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University Rishikul Campus Haridwar |
| Address |
OPD NO.7 Department of Shalya Tantra,Rishikul Ayurved Hospital, Rishikul Campus,Uttarakhand Ayurved University, Haridwar 249401 Uttarakhand India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7895985051 |
| Fax |
|
| Email |
himanirana113@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttarakhand Ayurved University Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University, Railway Road, Harrawala Dehradun |
| 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 |
| Himani |
Uttarakhand Ayurved University Rishikul campus, haridwar |
OPD NO.7 Department of Shalya Tantra,Rishikul Ayurved Hospital, Rishikul Campus,Uttarakhand Ayurved University, Haridwar 249401 Uttarakhand India
Hardwar
UTTARANCHAL |
07895985051
himanirana113@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Uttarakhand Ayurved University Rishikul campus |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: Gridhrasi (Sciatica), (2) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Sushrut shareer sthana, Procedure details: raktamokshans (15 -20ml) from most tender point)
| | 2 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Sushrut Shareer sthana, Procedure details: Press Katiktarun, kukundar, Janu & Gulph marma each one by one for 18 to 20 times.)
(1) Medicine Name: Aabhadi Churna, Reference: Yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient who have classical sign and symptoms of Gridhrasi.
Patients of age group between 16- 70 years.
Willingness of patients for study. |
|
| ExclusionCriteria |
| Details |
Pregnancy
Tuberculosis
Anaemia (Hb<10gm %)
Cardiac diseases
Uncontrolled Hypertension
Diabetes Mellitus
HIV positive
Hepatitis A, B, C positive
Malignancy of spine or other organs
History of spine fracture (trauma)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain (Ruka)
Stambha (Stiffness)
Aruchi (aversion of food)
Spandana (throbbing / pulsating)
Gaurava (heaviness) |
At 1st, 14th, 28th, 42nd days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gradation for S.L.R |
At 1st, 14th, 28th, 42nd days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/07/2023 |
| 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 study is a open label, randomized, parallel group control trial to determine the efficacy of Marma Chikitsa along with Aabhadi Churana in one group and Raktamoksana in another group for age group between 16- 70 years for 45 days. Study will be conduct at UAU, Rishikul Campus, Haridwar on 36 patients. Assessment will be done on the basis of subjective and objective parameters. Study will be conducted at OPD/IPD level of PG department of Shalya Tantra. Assessment will be done at the interval of 14 days of clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests. |