| CTRI Number |
CTRI/2022/07/043799 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2022 |
| 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
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF VRINDAMADHAVOKTA DASHAMULAADI KASHAYA IN THE MANAGEMENT OF GRIDHRASI WITH SPECIAL REFERENCE TO SCIATICA |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VRINDAMADHAVOKTA DASHAMULAADI KASHAYA IN THE MANAGEMENT OF GRIDHRASI WITH SPECIAL REFERENCE TO SCIATICA |
| Trial Acronym |
DMART |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd SNEHAL NAVNATH JAGTAP |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no.18, Department of kayachikitsa, Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9657247366 |
| Fax |
|
| Email |
jsnehal3333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M W Nalkande |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no.18, Department of kayachikitsa, Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9766694490 |
| Fax |
|
| Email |
mwnalkande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M W Nalkande |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no.18, Department of kayachikitsa, Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9766694490 |
| Fax |
|
| Email |
mwnalkande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored
Kayachikitsa department , Government ayurved college, vazirabad Nanded |
|
|
Primary Sponsor
|
| Name |
Snehal Navnath Jagtap |
| Address |
Room no 18, Department of kayachikitsa , Government Ayurved College, Nanded 431601 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Snehal Navnath Jagtap |
OPD kayachikitsa department |
Room no 18 Department of kayachikitsa, Government Ayurved College Nanded
Nanded
MAHARASHTRA |
9657247366
jsnehal3333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M544||Lumbago with sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashamulaadi Kashaya, Reference: Vrindamadhva, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Eranda taila ), Additional Information: -these kashaya will be given orally BD with Anupana Eranda taila 5 ml apane | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnasaptak Kashaya , Reference: Bhaishjyaratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -this kashaya will be given orally BD with Anupana koshna jal apane |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)subjects diagnosed as Gridhrasi with said diagnostic criteria
2) Patients willing for trial.
3) Irrespective of socioeconomic condition of patient
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactating women.
2. Patients with severe systemic disorders like severe cardiac disease, severe renal disease, cancerous condition.
3. Patient not willing to give written informed Consent.
4. If patient having traumatic injury
5. Patients with lumbar canal stenosis or other condition required surgical intervention
6. Patients with radiculopathy requiring surgical intervention.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Vrindamadhavokta Dashmulaadhi Kashaya orally in the management of Gridhrasi with special reference to Sciatica. |
31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the role of Vrindamadhavokta Dashmulaadhi Kashaya In relieving Ruk, Toda, Stambha, Spandan, Gaurava in Gridhrasi.To compare the effect of Vrindamadhvokt Dashmulaadi Kashaya and Rasnasaptak kwath with special reference to Sciatica. |
31 days |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 |
|
Date of First Enrollment (India)
|
15/07/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Randomized, controlled, clinical study of Vrindamadhavokta dashamulaadi kashaya 20 ml with Eranda taila 5 ml orally before meals BD for 30 days and follow up on 10th , 20th, 31st day .This study is conducted as PG course at single center. The primary outcome is to study the efficacy of Vrindamadhavokta Dashmulaadhi Kashaya orally in the management of Gridhrasi with special reference to Sciatica. |