| CTRI Number |
CTRI/2025/04/084332 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Procedure ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Agnikarma by Panchadhatu shalaka in the management of Gridhrasi. |
|
Scientific Title of Study
|
A Randomised Comparative clinical trial to evaluate the effect of Agnikarma
by Panchadhatu shalaka among two different sites 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 |
Dr Sanket Sunil Sangale |
| Designation |
PG Scholor |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25, Nigdi Pradhikaran,Pune
Pune MAHARASHTRA 411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9689768608 |
| Fax |
|
| Email |
sanketsangle2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25, Nigdi Pradhikaran,Pune
Pune MAHARASHTRA 411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25, Nigdi Pradhikaran,Pune
Pune MAHARASHTRA 411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Nigdi Pradhikaran,Pune,Maharashtra, 411044,India |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25, Nigdi Pradhikaran,Pune
Pune MAHARASHTRA 411044
India |
| 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 Sanket Sunil Sangale |
Ayurved Rugnalya And Snowbell Multi-speciality Hospital |
Ayurved Rugnalya And Snowbell Multi-speciality Hospital, Shalyatantra Department,OPD No 123A Nigdi Pradhikaran,411044,Pune, Maharashtra
Pune
MAHARASHTRA |
9689768608
sanketsangle2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Charaka Samhita of charak, chikitsa, Procedure details: Purvakarma –
1.Written consent
2. Patient will be advised to lie down on bed in right/left lateral position
according to the affected leg.
Pradhan Karma –
1.Points of gulpha pradesh are assessed & marked.
2. Agnikarma will be done by conduction method at the point of gulpha
pradesh.
3. Procedure will be stopped when patient feels atmost heat.
Pashchat Karma -
After Agnikarma immediately Ghruta will be applied.
( Agnikarma will done on 0 , 7th, 14th & 21st day. ))
| | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita Chikitsa Sthana, Procedure details: Agnikarma :-
• Purvakarma -
1.Written consent
2. Patient will be advised to lie down on bed in right/left lateral position
according to the affected leg.
• Pradhan Karma -
1.Points of maximum tenderness are assessed & marked.
2. Agnikarma will be done by conduction method at the point of maximum
tenderness.
3.Procedure will be stopped when patient feels atmost heat.
• Pashchat Karma –
After agnikarma immediately Ghruta will be applied.
( Agnikarma will done on 0 , 7th, 14th & 21st day. ))
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical clinical features
of Gridhrasi that is Ruka,Toda,Stambha,Suptata in Sphik,Kati,Uru,Janu,Jangha and Pada, Irrespective of religion,Caste,Gender and Socioeconomic status. |
|
| ExclusionCriteria |
| Details |
Pregnancy,DM
K/C/O-Tuberculosis, Cardiac diseases, Spondylolisthesis, Sarcoiliac arthritis, Dislocation, Fracture,Ligaments tear, HTN |
|
|
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 |
| Improvement in Ruka,Toda,Stambha,Suptata will be assessed on 7th,14th and 21st day after intervention. |
Improvement in Ruka,Toda,Stambha,Suptata will be assessed on 7th,14th and 21st day after intervention. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/04/2025 |
| 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
|
Ayurveda mentions a disease called as Gridhrasi under the cluster of
Nanatmaj vyadhi of vata i.e. where only vitation of vata dosha occurs.
In this disease, piercing pain starts from the sphik pradesh radiating
to kati , prushta , uru , janu , jangha & pada . Also stambha , toda , spandan
is experienced by the patient.
Patient experiences sakhtiutkshepa , nighraha i.e. unability to lift
the leg & hence has restricted movements.
Gridhrasi in Sanskrit describes a particular type of gait of the
patient where in the patient resembles the bird vulture. i.e. legs look a bit
tensed and slightly curved.
Aacharya sushrut states that when vata dosha is vitated and affects
the heel and toe area. It leads to restricted movements of the leg that
gives rise to the disease – Gridhrasi. RATIONALE OF STUDY: -
• There is a need to introduce a minimal invasive and instant pain-
relieving treatment modality in Gridhrasi. It has been very well
explained in Ayurvedic scriptures.
• The research formulation mentioned to treat gridhrasi in
ayurvedic Samhita is beneficial . The research comprises the
agnikarma by panchadhatu shalaka which has qualities of vata
shaman . |