| CTRI Number |
CTRI/2020/02/023286 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
10/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Punarnavadi Churna with and without Agnikarma in Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Punarnavadi Churna with and without Agnikarma in Gridhrasi (Sciatica) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amey Chandrakant Nakil |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya, Solapur |
| Address |
Seth Govindji Raoji Ayurved Mahavidyalaya, Ground floor, Department of Kayachikitsa, 21/A/13,Budhwar Peth,solapur, Maharashtra
Solapur
MAHARASHTRA
413002
India |
| Phone |
8793745757 |
| Fax |
0217-2728385 |
| Email |
amey.nakil007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channamma Hiremath |
| Designation |
Professor of Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya, Solapur |
| Address |
Seth Govindji Raoji Ayurved Mahavidyalaya, Ground floor, Department of Kayachikitsa, 21/A/13,Budhwar Peth,solapur, Maharashtra
Solapur
MAHARASHTRA
413002
India |
| Phone |
9890630015 |
| Fax |
0217-2728385 |
| Email |
c.s.hiremath13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amey Chandrakant Nakil |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya, Solapur |
| Address |
Seth Govindji Raoji Ayurved Mahavidyalaya, Ground floor, Department of Kayachikitsa, 21/A/13,Budhwar Peth,solapur, Maharashtra
Solapur
MAHARASHTRA
413002
India |
| Phone |
8793745757 |
| Fax |
0217-2728385 |
| Email |
amey.nakil007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand jain Ayurved Rugnalaya, 118/119, Shukrawae Peth, Tilak Chowk, Solapur, Maharashtra 413002. |
|
|
Primary Sponsor
|
| Name |
Dr Amey Chandrakant Nakil |
| Address |
Seth Sakharam Nemchand jain Ayurved Rugnalaya, 118/119, Shukrawae Peth, Tilak Chowk, Solapur, Maharashtra 413002. |
| 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 Amey Chandrakant Nakil |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya |
Kayachikitsa OPD no-3, 118/119, Shukrawar Peth, Tilak Chowk, Solapur, Maharashtra 413002.
Solapur
MAHARASHTRA |
8793745757
0217-2728385
amey.nakil007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Punarnavadi Churna |
Group B will be treated with Punarnavadi Churna in the age group of 20 to 60 years. Punarnavadi Churna will be given orally in the dose of 3gm twice a day before meal with luke warm water which includes follow up on 7th,14th,21th,28th day.
|
| Intervention |
Punarnavadi Churna With Agnikarma |
Group A will be treated with Punarnavadi Churna and Agnikarma in the age group of 20 to 60 years. Punarnavadi Churna will be given orally in the dose of 3gm twice a day before meal with luke warm water And Agnikarma will be done with Loh Shalaka in 4 settings which includes follow up on 7th,14th,21th,28th day.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are having 2 or more following symptoms will be included
a. Shoola (Pain)
b. Stambha (Stiffness)
c. Toda (Pricking sensation)
d. Padasuptata (Numbness)
e. Gaurava (Heaviness)
f. Shaktikshepa Nighraha (Unable to lift the leg)
2.Patients fit for Agnikarma. |
|
| ExclusionCriteria |
| Details |
1.Known case of Auto-Immune disorders.
2.Known case of Uncontrolled Diabetes Mellitus.
3.Known case of fracture of Lumbar Vertebrae and Dislocation of Hip joint.
4.Known case of Trauma.
5.Pregnant and lactating women.
6.Bhiru (Afraid of Agnikarma).
7.Sukumar (Unable to take Agnikarma)
|
|
|
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 |
| To evaluate the efficacy of Punarnavadi Churna with and without Agnikarma in the management of Gridhrasi(Sciatica). |
28 days with follow up on 7th,14th,21th,28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study individual effect of Punarnavadi Churna in Gridhrasi (Sciatica).
2.To study the combine effect of Punarnavadi Churna with Agnikarma in Gridhrasi (Sciatica).
3.To study mode of action of Agnikarma in Ayurveda. |
28 days with follow up on 7th,14th,21th,28th day. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/02/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Gridrasi (Sciatica) is one among the major crippling diseases which mentioned under nanatmaja vata vyadhis. Gridhrasi which cripples the life of person by causing Radiating pain from Sphik-kati-Prushtha-Uru-Janu-Pad kramagat in leg while in movements or rest as well.The main objective of this research work is to provide proper report on efficacy of Punarnavadi Churna with and without Agnikarma in the management of Gridhrasi (sciatica). |