| CTRI Number |
CTRI/2024/10/075987 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of nimbadi guggulu and shadbindu ghrit nasya in ardhavbhedak |
Scientific Title of Study
Modification(s)
|
A comparative clinical study to evaluate the efficacy of nimbadi guggulu and shadbindu ghrit nasya in the management of ardhavbhedak w.s.r to migraine |
| 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 Ayushi chhipa |
| Designation |
Pg scholar |
| Affiliation |
Madan mohan malviya govt. ayurved college udaipur rajasthan |
| Address |
Pg department of kaya chikitsa madan mohan malviya govt. ayurved college udaipur rajasthan
Pg department of kaya chikitsa madan mohan malviya govt. ayurved college udaipur rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9799419099 |
| Fax |
|
| Email |
ayuchhipa98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi sharma |
| Designation |
Professor and hod |
| Affiliation |
madan mohan malviya govt. ayurved college udaipur rajasthan |
| Address |
Pg department of kaya chikitsa madan mohan malviya govt. ayurved college udaipur rajasthan
Pg department of kaya chikitsa madan mohan malviya govt. ayurved college udaipur rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414419259 |
| Fax |
|
| Email |
rspgkcj2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi chhipa |
| Designation |
Pg scholar |
| Affiliation |
madan mohan malviya govt. ayurved college udaipur rajasthan |
| Address |
Pg department of kaya chikitsa madan mohan malviya govt. ayurved college udaipur rajasthan
Pg department of kaya chikitsa madan mohan malviya govt. ayurved college udaipur rajasthan
Udaipur
RAJASTHAN
311404
India |
| Phone |
9799419099 |
| Fax |
|
| Email |
ayuchhipa98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya Govt.Ayurved College Udaipur |
|
|
Primary Sponsor
|
| Name |
Mmm govt ayurved college udaipur |
| Address |
Madan mohan malviya govt. ayurved college udaipur rajasthan |
| Type of Sponsor |
Government 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 Ayushi chhipa |
Madan mohan malviya government ayurved college udaipur rajasthan |
Pg dept. of kaya chikitsa opd no. 1 rajkiya ayurved chikitsalaya moti chohatta hathipole udaipur
Udaipur
RAJASTHAN |
9799419099
ayuchhipa98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee madan mohan malviya govt. ayurved college udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R51||Headache. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NIMBADI GUGGULU, Reference: Vrihat nighantu ratnakar, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Vanga sen samhita , Procedure details: 6 drop each nostril early in the morning with shadbindu ghrit)
(1) Medicine Name: SHADBINDU GHRIT, Reference: Vanga sen siroroojadhikar, Route: Nasal, Dosage Form: Ghrita, Dose: 6(drops), Frequency: od, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing for trial.
2.chronicity not exceeding more than 10 years. |
|
| ExclusionCriteria |
| Details |
1.Age beloe 18 or more than 70 years.
2.who are taking other preventive treatment.
3.suffering from other chronic diseases.
4.suffering from secondary headache of meningitis , brain tumor , encephalitis or having referred pain on one half of the head due to disorders of eye, ear, nose, throat etc.
5.Evidence of significantly active psychiatric disease including manic depressive illness , schizophrenia, genralized anxiety disorder , OCD , and personality disorder.
6.Women who are pregnant or nursing.
7.Patients with excessive alcoholic ,opiate, barbiturate use.
8.Pt. with h/o drug dependence or drug abuse. |
|
|
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 |
| Chnages in subjective and objective criteria of Ardhavbhedak (migraine) |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of treatment |
15th day, 30th day, 45th day, 60th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/11/2024 |
| 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="0"
Months="2"
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
|
A clinical comparative study to evaluate the efficacy of nimbadi guggulu and shadbindu ghrit nasya in the management of Ardhavbhedak w.s.r to migraine. There will be 3 group in the study . In group A randomly selected and clinically diagnosed 20 patients of Ardhavbhedak will be given nimbadi guggulu twice a day. In group B 20 patients will be given shadbindu ghrit nasya once a day early in morning for 7 days and after gap of 10 days shall be repeated in next 2 sessions. In group C 20 patients will be given nimbadi guggulu twice a day and shadbindu ghrit nasya once a day early in the morning for 7 days and after gap of 10 days shall be repeated in next 2 sessions . trial will be conduct for a period of 2 months. Follow up of the cases will be after every 15 days that is 4 times during treatment. Final assessment will be done after completion of 2 months course on the basis of subjective and objective assessment. The data will be analyzed scintifically and statistically. |