| CTRI Number |
CTRI/2024/08/072207 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Snehapurvak Siravedha in Grudhrasi with special reference to Sciatica |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Study the effect of Snehapurvak Siravedha in Grudhrasi with special reference to 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 Akshaya Anil Toraskar |
| Designation |
PG Scholar |
| Affiliation |
SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik |
| Address |
Department of Panchakarma
SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8454956050 |
| Fax |
|
| Email |
anaghatoraskar19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Kurawar |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik |
| Address |
Department of Panchakarma SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8793655354 |
| Fax |
|
| Email |
rashmikurawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshaya Anil Toraskar |
| Designation |
PG Scholar |
| Affiliation |
SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik |
| Address |
Department of Panchakarma
SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8454956050 |
| Fax |
|
| Email |
anaghatoraskar19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Akshaya Anil Toraskar |
| Address |
SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Nashik 422403 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 Akshaya Anil Toraskar |
SMBT Ayurved College and Hospital |
OPD No 13 Department of Panchkarma SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA |
8454956050
anaghatoraskar19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
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 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Charak Chikitsa adhaya 28 sholk number 101, Procedure details: PURVAKARMA
Local Abhyanga & Swedan of selected patients. Internal Snehapan will not be done in this group.
PRADHANKARMA
Siravedh will be carried in 2 sittings with a gap of 7 days. Selected site according to Charaka Antara Kandara of Gulpha Sthana. Blood letting of 100ml to 120ml will be done depending on the condition of patients. Look for Samyakyog Ayoga & Atiyog lakshan.
PASCHATKARMA
Dressing & proper compression, removal of needle followed by sterile cotton pad application & compression bandaging will be done
Rest for 10 to 15 mins & vitals will be monitored.)
| | 2 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Charak Chikitsa adhaya 28 sholk number 101, Procedure details: PURVAKARMA
For this group Internal Snehapan with Goghrit will be done in Vardhaman Matra of 30ml 60ml & 90ml for 3 days. Local Abhyanga and Swedan on the day of Siravedh.
PRADHANKARMA
Siravedh will be carried in 2 sittings with a gap of 7 days. Selected site according to Charaka Antara Kandara of Gulpha Sthana. Blood letting of 100ml to 120ml will be done depending on the condition of patients. Look for Samyakyog Ayoga and Atiyog lakshan.
PASCHATKARMA
Dressing and proper compression, removal of needle followed by sterile cotton pad application and compression bandaging will be done
Rest for 10 to 15 mins and vitals will be monitored.)
(1) Medicine Name: goghrit, Reference: charak samhita, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Grudhrasi like PadaKramat Vedana, Toda, Pada suptata.
Age between 30 years to 60 years.
Patients having confirmed the diagnosis by using SLR test. |
|
| ExclusionCriteria |
| Details |
Patients with diabetes and cardiovascular disease, immunocompromised, traumatic, infective, neoplastic spine.
Anemic patients with Hb less then 9.
Pregnant women.
Patients age below 30 years and above 60 years.
Anatomical deformities like varus, vulgus, kyphosis, lordosis, scoliosis, spina bifida etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Ghrudhrasi |
12 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| where trial group is more effective than control group in reducing sign & symptoms of Grudhrasi |
18 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
19/08/2024 |
| 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 Yet Recruiting |
| 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 population based study from India to report on Grudhrasi shows that the prevalence of Grudhrasi was 14%. In this disease pain is severe and affects the daily work and lifestyle, so there is a need to discover better and different treatment therapies in this painful condition. Present study of Randomized Controlled Clinical Trial will be carried out to study the effect of Snehapurvak Siravedha in Grudhrasi with special reference to Sciatica. For present study subjects between age group 30-60 years will be taken irrespective of religion, gender, socioeconomic status. Sample size found was 32, considering drop out rate of 10% 36 was decided. Total 72 patients will be taken for the study, 36 patients in group A (Trail group) and 36 patients in group B (Control Group). Snehapurvak Siravedha is taken in group A (Trial group) and Asnehapurvak Siravedha is taken in group B (Control Group). Group A will be given Goghrit in Vardhaman Matra of 30ml, 60ml, and 90ml for 3 days followed by Abhyanga, Swedana and then Siravedha on 4th day. Next 2nd sitting will be carried out after 7 days on 12th day with prior 3 days of Snehapana. For group B, only Abhyanga and Swedana followed by Siravedha on the same day will be done in 2 sittings. SOP will be followed, all findings will be entered in case record form. Observation will be drawn before, during and after treatment. Results will be drawn with the help of Statistical method. Discussion will be one on the basis of Observations. Summary will be drawn. Conclusion will be drawn strictly on the basis of Statistical Analysis and will be unbiased. |