| CTRI Number |
CTRI/2025/02/080187 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study Of Marma And Agnikarma In The Pain Management Of Sciatica |
|
Scientific Title of Study
|
Compative Study Of Efficacy Of Marma Chikitsa And Agnikarma In The Pain Management Of Gradhrasi(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 Anjali Sadani |
| Designation |
Md Scholar Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
Pg Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
7049270544 |
| Fax |
|
| Email |
anjalisadani00@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rita Marwaha |
| Designation |
Professor And Hod Department Of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt.(Auto) Ayurveda College and Institute Bhopal Madhya Pradesh. |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh. Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh Bhopal MADHYA PRADESH 462003 India |
| Phone |
9425679777 |
| Fax |
|
| Email |
marwaharita@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anjali Sadani |
| Designation |
MD Scholar Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College and Institute
Bhopal Madhya Pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
7049270544 |
| Fax |
|
| Email |
anjalisadani00@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
| Type of Sponsor |
Government funding agency |
|
|
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 Anjali Sadani |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh Bhopal MADHYA PRADESH |
7049270544
anjalisadani00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pandit Khushilal Sharma Govt Auto Ayurveda College and Institute Bhopal Madhya Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G541||Lumbosacral plexus disorders. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•ितà¥à¤¸à¤¾ | (Procedure Reference: DR SUNIL KUMAR JOSHI, Procedure details: STIMULATION OF MARMA STHANA FOR 0.8 SEC, 15-18 TIMES, ONCE A DAY)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: CHARAK AND SUSHRUTA SAMHITA, Procedure details: 4 ANGULA ABOVE GULPHA SANDHI ON POSTERIOR SIDE OF AFFECTED LEG, 15-18 BINDU OF SAMYAK DAGDHA WITH PANCHDHATU SHALAKA)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex in the age group of 20 to 60 years.
2.Clinical signs and symptoms of gradhrasi present in the classical text
3.Tenderness at the course of Sciatic Nerve.
4.Severe pain on squatting.
5. Patient willing to be registered for study. |
|
| ExclusionCriteria |
| Details |
1.Fracture related to spine and lower limb
2.Patients who are suffering from any systemic or metabolic disorders
3.Traumatic Infective Neoplastic conditions of spine
4.Patient having Hemoglobin less then 07.00 mg/dl
5.Cardiac diseases
6.Pregnant and lactating women
7.Patient having any hematological and bleeding disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It Is Expected That At The End Of Study Scholar Will Be Able To Evaluate The Effect Of Marma Chikitsa And Agnikarma In The Pain Management Of Gradhrasi(Sciatica). |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marma Chikitsa Is a Non Pharmaceutical Approach To Manage Pain In Gradhrasi(Sciatica). |
21 Days |
|
|
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)
|
10/02/2025 |
| 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 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
|
The prevalence of Gridhrasi (Sciatica) is notably high, impacting over 75% of the global population. This condition presents with symptoms such as Ruja, Toda, and Stambha, starting in the Sphika and extending down to the Kati-Prishtha, Janu, Urn, and Pada. Marma Chikitsa is a non-invasive and natural approach to healing that aligns with the principles of holistic well-being. |