| CTRI Number |
CTRI/2024/05/067889 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Brihat panchamoola ghana vati and fomentation therapy with eranda patra in Gridhrasi or sciatica |
|
Scientific Title of Study
|
A clinical evaluation of Brihat panchmoola ghana vati and Eranda patra pottali sweda in the management of Gridhrasi 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 Rohit Kumar Mishra |
| Designation |
Junior Resident |
| Affiliation |
BHU |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical Sciences BHU
Varanasi
UTTAR PRADESH
221005
India
Sir Sunder Lal Hospital
Institute of Medical Sciences BHU
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07007879201 |
| Fax |
|
| Email |
mishrarohithdi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant Professor |
| Affiliation |
BHU |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical Sciences BHU
Varanasi
UTTAR PRADESH
221005
India
SSH IMS BHU
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant Professor |
| Affiliation |
BHU |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical Sciences BHU
Varanasi
UTTAR PRADESH
221005
India
SSH IMS BHU
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Faculty of Ayurveda IMS BHU Varanasi Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Kumar Mishra |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical Sciences BHU
Varanasi
UTTAR PRADESH
221005
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 Rohit Kumar Mishra |
Sir Sunder Lal Hospital Institute of medical Sciences Banaras Hindu University |
Kayachikitsa OPD 21 and 22
Panchkarma OPD 16C
Varanasi
UTTAR PRADESH |
07007879201
mishrarohithdi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brihat Panchmoola Ghan Vati, Reference: Chakradutta Vata Vyadhi 22/42, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Eranda Tail), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Control Group | Tab. Methylcobalamin 1500 mcg OD for 45 days | | 3 | Comparator Arm | Procedure | - | svedanam, सà¥à¤µà¥‡à¤¦à¤¨à¤®à¥ | (Procedure Reference: Arogya Kalpadrumah 17/36-37, Procedure details: Patra pottali sweda along with Brihat panchamoola ghana vati for 45 days)
(1) Medicine Name: Brihat panchamoola ghana vati , Reference: Chakradutta Vata vyadhi 22/42, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 20 to 60 years (irrespective of sex, race, caste, religion)
2.On the basis of sign and symptoms mentioned for Gridhrasi (either vataj or vata kaphaj)
3.SLR i.e. straight leg raising test, Bragard’s test (Lasegue test) positive
4.Patient willing for enroll in trial study.
5.Patient who are not taking any other medication for Gridhrasi.
|
|
| ExclusionCriteria |
| Details |
1.Age below 20 and above 60 years.
2.Patients having complications like uncontrolled diabetes mellitus, hypertension, tuberculosis of spine, fracture related to spine or malignancy of spine.
3.Known case of Cardiac diseases (ischemic heart disease, trauma, coronary artery disease, myocardial infarction etc.)
4.Pregnancy, Lactating Mother.
5.Any other chronic illnesss like T.B. etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in symptoms like
Ruka (Pain)
Toda (Pricking sensation)
Stambh (Stiffness)
Spandan (Twitching)
Aruchi (Anorexia)
Tandra (Drowsiness)
Gaurava (Heaviness)
|
Evalutaion will be done in 15th, 30th, and 45th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement on symptomatic relife in sciatica symptoma |
Evaluation on assesment basis will be done after 15 30 & 45 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/06/2024 |
| 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="0"
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
|
90 cases of Gridhrasi will be included in this interventional study which will be randomly divided into 3 groups of 30 patients in each group. One group will be prescribed Brihat panchmoola ghana vati 500 mg BD for 45 days.Second group will be prescribed Brihat panchmoola ghana vati 500 mg BD along with Eranda patra pottali sweda for 7 days at every follow up.Third group will be given only Tab Methylcobalamine 1500mcg OD. The study will be conducted for 45 days with 3 follow up after every 15 days. |