| CTRI Number |
CTRI/2023/11/060375 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effect of agnikarma and additional effect of shivaguggul with agnikarma in gridhrasi (sciatica) |
|
Scientific Title of Study
|
Randomized comparative clinical study to evaluate the add on effect of shiva guggul
with Agnikarma in 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 |
Dr Harsh Ananda Naikwadi |
| Designation |
PG Scholar |
| Affiliation |
P.D.E.As College of Ayurved and Research Center, Nigadi, Pune |
| Address |
PDEAS College of Ayurved and Research Centre, Third floor,
Shalyatantra department Sector no. 25, Nigdi Pradhikaran, Pune
411044
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
7038834045 |
| Fax |
|
| Email |
harshiv4045@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Mendhekar |
| Designation |
Asso. Professor |
| Affiliation |
P.D.E.As College of Ayurved and Research Center, Nigadi, Pune |
| Address |
PDEAS College of Ayurved and Research Centre, Third floor,
Shalyatantra department Sector no. 25, Nigdi Pradhikaran, Pune
411044
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
9867802319 |
| Fax |
|
| Email |
doctor.kiran.mendhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Ananda Naikwadi |
| Designation |
PG Scholar |
| Affiliation |
P.D.E.As College of Ayurved and Research Center, Nigadi, Pune |
| Address |
PDEAS College of Ayurved and Research Centre, Third floor,
Shalyatantra department Sector no. 25, Nigdi Pradhikaran, Pune
411044
MAHARASHTRA
Pune
MAHARASHTRA
411044
India |
| Phone |
7038834045 |
| Fax |
|
| Email |
harshiv4045@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Centre, Sector no. 25, Nigdi Pradhikaran, Pune |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research Centre, Sector no. 25, Nigdi Pradhikaran, Pune |
| Address |
PDEAS College of Ayurved and Research Centre, Third floor,
Shalyatantra department Sector no.25,Nigdi Pradhikaran, Pune411044 MAHARASHTRA |
| Type of Sponsor |
Private 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 Harsh Naikawadi |
Ayurved Rugnalaya and Sterling Multi-Speciality Hospital, |
Ayurved Rugnalaya and Sterling Multi-Speciality Hospital, Shalyatantra Department, OPD no 123A, Sector no 27, Pradhikaran Nigdi, Pune
Pune
MAHARASHTRA |
703834045
harshiv4045@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, College of Ayurved and research Center, Pune, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut chikitsa sthan adhyay 4 shlok 8 , Procedure details: Agnikarma (bindu prakar) will be done by conduction method using panchdhatu shalaka
consent will be taken
points of tenderness will be marked using a marker
cleaning & draping will be done
Shalaka will be held in artery forceps and applied to the marked site, heat will be given using a candle on the other end of the shalaka
As the metal shlaka heats up patient will gradually feel the heat
When the point of maximum tolerable heat is crossed shalaka will be withdrawn
)
(1) Medicine Name: Shiva guggul, Reference: Bharat bhaishajya Ratnakar, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut chikitsa 4 shlok 8 , Procedure details: Agnikarma (bindu prakar) will be done by conduction method using panchdhatu shalaka
consent will be taken
points of tenderness will be marked using a marker
cleaning and draping will be done
Shalaka will be held in artery forceps and applied to the marked site, heat will be given using a candle on the other end of the shalaka
As the metal shlaka heats up patient will gradually feel the heat
When the point of maximum tolerable heat is crossed shalaka will be withdrawn
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Grishrasi
Suptata (Stiffness), Stambha (Numbness), Aruchi (Anorexia), Tandra(Drowsiness),
Gaurav (Heaviness),Spandana(throbbing) in sphik,kati, uru, janu, Jangha and
Pada |
|
| ExclusionCriteria |
| Details |
(1) Pregnant women
(2) K/C/O Uncontrolled diabetes mellitus, diabetic neuropathies and
Accelerated hypertension.
(3) K/C/O Tuberculosis of spine and hip joint.
(4) Patient with Malignancy of spine or other organs.
(5) Fracture and tumor related to spine, hip bone and femur.
(6) Patient suffering from major trauma having dislocation of hip joint.
(7) Patient with K/C/O Cardiac diseases (ischemic heart disease,
coronary artery disease, myocardial infarction)
(8) Known case of Spondylolisthesis, Sacroiliac arthritis and multiple
wounds. |
|
|
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 |
| A clinical study to access the effect of agnikarma and add on effect of shivaguggul with agnikarma in reducing tod (pricking pain) sthambha (stiffness) spandan (throbbing) in gridhrasi (sciatica) |
Patient assessment on seventh fourteenth and twenty first day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study adverse effects, if any |
Patient assessment on seventh fourteenth & twenty first day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2023 |
| 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="0"
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
|
Basically, ayurveda is mainly based on the concepts of Tridosha i.e., vata, pitta and kapha among this all Vata is the main dosha. All vata vyadhi described in Samhita’s thoroughly, in that all vata vyadhi Gridhrasi is one of the Vata vyadhi which have symptoms mainly mentioned as - Pain starts from sphik pradesh and radiating downwards to the kati pradesh and it continuous to prushtha pradesh, uru Pradesh, Janu Pradesh, Jangha Pradesh. In gridhrasi patient is unable to walk properly. This is similar to sciatica in modern science by its signs and symptom. Symptomatically it had some other problems too, in which pain begins in lumbar region and radiates posterio-lateral aspects of thigh and leg one lower limb or both lower limbs, for this Agnikarma is performed it will give instant relief from pain and other symptoms without any side effect. |