| CTRI Number |
CTRI/2025/12/099985 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| 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
|
Evaluate the efficacy of Rudrakshadi Yoga in the management of Ardhavbhedaka w.s.r. to Migraine |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Study to evaluate the efficacy of Rudrakshadi Yoga in the Management of Ardhavabhedaka 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 Vijayant Bhardwaj |
| Designation |
HOD Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
HOD Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangeeta |
| Designation |
Pg scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219122465 |
| Fax |
|
| Email |
sangeetasangil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,
Paprola, Distt. Kangra, H.P. 176115, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijayant Bhardwaj |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
OPD No. 201, Rajiv
Gandhi Govt Post
Graduate Ayurvedic
College and Hospital,
Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418017568
bhardwajvijayant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Rudrakshadi Yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Caffeine(100 mg),Ergotamine(1mg), Paracetamol(250mg),Prochlorperazine(2.5mg) | |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group above 18 years will be selected for the study.
2. Patients willing to participate and able to provide signed informed consent.
3. Patient with sign and symptoms of Ardhavbhedak given as per Ayurvedic and modern literature. |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to any of the trial drug or other ingredients.
2. Individuals who have completed participation in any other clinical trial during the past six months.
3. Patients with status migrainosus, ophthalmic migraine or hemiplegic migraine.
4. Patients with chronic renal failure, diabetes mellitus, HTN will be excluded.
5. Any other condition which the principal investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of Migraine in patient
|
21 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Rudrakshadi yoga in the management of Migraine w.s.r. to Ardhavbhedaka |
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/04/2026 |
| 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 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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital,Paprola. 2 groups each of 15 patients will be registered and assessed to evaluate the efficacy of Rudrakshadi Yoga in the management of Ardhavbhedaka w.s.r. to Migraine |