| CTRI Number |
CTRI/2025/03/083352 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of Pathyadi Kwath and Rasnadi Kwath in the management of Ardhavbhedak (Migraine) |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Pathyadi Kwath and Rasnadi Kwath 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 Monika Mittal |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurvedic College, Udaipur |
| Address |
20, Hardeva Vihar, Beri Wala Bagh, Near Jaipaltan Road, Alwar, Rajasthan (301001)
OPD no. 9 and 10, PG dept. of Shalakya Tantra, Madan Mohan Malviya Government Ayurved College, Ambamata, Udaipur (Rajasthan)
Udaipur
RAJASTHAN
301001
India |
| Phone |
8949721283 |
| Fax |
|
| Email |
monikamittal1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor and HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurvedic College, Udaipur |
| Address |
PG department of Shalakya Tantra, Madan Mohan Malviya Government Ayurvedic College, Udaipur
Ambamata, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor and HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurvedic College, Udaipur |
| Address |
PG department of Shalakya Tantra, Madan Mohan Malviya Government Ayurvedic College, Udaipur
Ambamata, Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurvedic College, Ambamata, Udaipur, Rajasthan, India, pin code: 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurveda College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurveda College and Hospital, Ambamata, Udaipur, Rajasthan, India, Pin code : 313001 |
| 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 Monika Mittal |
Madan Mohan Malviya Government Ayurveda College, Udaipur |
OPD no. 9 and 10, PG department of Shalakya Tantra, Madan Mohan Malviya Govt. Ayurved College and Hospital, Ambamata, Udaipur
Udaipur
RAJASTHAN |
8949721283
monikamittal1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee M.M.M. Govt. Ayurved College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G40-G47||Episodic and paroxysmal disorders. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Kwath, Reference: Brihata Nighantu Ratnakar, Volume 6, page no. 406, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi Kwath, Reference: Sharangdhar Samhita, Madhyam Khand, Chapter 2, Shloka 143-145, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients willing for trial and ready to given written consent.
ii) Age between 18 to 60 years.
iii) Patient of any sex.
iv) Chronicity not exceedingly more than five years.
|
|
| ExclusionCriteria |
| Details |
i) Age below 18 or more than 60 years.
ii) Patients of migraine who are taking other preventive treatment.
iii) Patients who are suffering from other chronic diseases like DM, HTN, etc.
iv) Patients who are 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.
v) Evidence of significantly active psychiatric disease including manic depressive illness, schizophrenia, generalized anxiety disorder, OCD, and personality disorder.
vi) Women who are pregnant or nursing.
vii) Patients with excessive alcoholic, opiate, barbiturate use and have history of drug dependence or drug abuse.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Treatment in Improving Sign and Symptoms of disease |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Associated Sign and Symptoms of disease |
45 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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
|
This is a clinical trial to compare efficacy of Pathyadi Kwath and Rasnadi Kwath in the management of Ardhavbhedak with special reference to Migraine. In this trial 2 groups each of 30 patients will be selected. Group A will be administered with Pathyadi Kwath 40ml BD with anupana of gud. Group B will be administered with Rasnadi Kwath 40ml BD.
|