| CTRI Number |
CTRI/2022/05/042700 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study effect of Ayurvedic medicines in Migraine |
|
Scientific Title of Study
|
A randomized clinical trial on the comparative efficacy of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi Ghan Vati orally in Ardhavabhedaka with special reference to Migraine
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahima Choudhary |
| Designation |
P.G. Scholar |
| Affiliation |
National Institute of Ayurveda (Deemed to be university) Jaipur |
| Address |
P.G. Department of Shalakya Tantra National Institute of Ayurveda (Deemed to be university)Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461267615 |
| Fax |
|
| Email |
mahimachoudhary7615@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Sharma |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda (Deemed to be university) Jaipur. |
| Address |
P.G. Department of Shalakya Tantra National Institute of Ayurveda (Deemed to be university) Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955688129 |
| Fax |
|
| Email |
appu07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Choudhary |
| Designation |
P.G. Scholar |
| Affiliation |
National Institute of Ayurveda (Deemed to be university) Jaipur. |
| Address |
P.G. Department of Shalakya Tantra National Institute of Ayurveda (Deemed to be university) Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461267615 |
| Fax |
|
| Email |
mahimachoudhary7615@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Jorawar Singh Gate, Amer Road,Jaipur (Raj.) 302002 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahima Choudhary |
National Institute of Ayurveda (Deemed to be university) Jaipur |
P.G. Department of Shalakya Tantra Madhav Vilas Palace Jaipur Room No.13 ( ENT OPD )
Jaipur
RAJASTHAN |
9461267615
mahimachoudhary7615@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gandharyadi Ghrita, Reference: Vrihat Nighantu Ratnakar Commentary by Shree Dat Ram Shree Krishnlal Mathur, Khemraj Shree Krishn Das Prakashan Bombay, Reprint 1995, p. 403, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: Nasya with Gandharyadi Ghrita is given for a duration of 7 days followed by 7 days gap between two sittings (2) Medicine Name: Dhatryadi Ghan Vati, Reference: Vangasena Samhita Cikitsa sara Samgraha by Dr. Nirmal Saxena,Chaukhamba Sanskrit Series Varanasi, chap. 72/114-115, p.957, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: b, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmooladi Ghrita, Reference: Vangasena Samhita Cikitsa sara Samgraha by Dr. Nirmal Saxena,Chaukhamba Sanskrit Series Varanasi, chap. 72/105, p.956, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: Nasya with Dashmooladi Ghrita is given for a duration of 7 days followed by 7 days gap between two sittings (2) Medicine Name: Dhatryadi Ghan Vati, Reference: Vangasena Samhita Cikitsa sara Samgraha by Dr. Nirmal Saxena,Chaukhamba Sanskrit Series Varanasi, chap. 72/114-115, p.957, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days|, anupAna/sahapAna: No, Additional Information: |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to participate in this trial through written informed consent.
2.Both fresh and treated patients.
3.Patients between18 to 60 years of age from either sex.
4.Patients presenting with symptoms of Ardhavabhedaka vis-Ã -vis Migraine.
|
|
| ExclusionCriteria |
| Details |
1.Patients of age less than 18 and greater than 60
2.Patients with referred pain in one half of head due to other secondary reasons such as anxiety, refractive errors etc. rather than migraine.
3.Patients with complicated Migraine like hemiplegic migraine and having any chronic debilitating disease with other neurological pathology.
4.Pregnant and lactating women.
5.Patients suffering from any other major systemic disorders which interfare with course of treatment. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in intensity/ duration/ frequency of headache (MIDAS/ VAS)
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in other associated symptoms of migraine:
1.Nausea
2.Vomiting
3.Photophobia
4.Sleep disturbance |
31days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/06/2022 |
| Date of Study Completion (India) |
30/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
AIMS AND OBJECTIVES Aim- To conduct a randomized clinical trial on comparative efficacy of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi Ghan Vati in the management of Ardhavbhedaka with special reference to Migraine. Objectives- 1. To study and establish a conceptual correlation between Ardhavabhedaka and Migraine. 2. To evaluate and compare the efficacy of trial drugs in ardhavabhedaka and Migraine. RESEARCH QUESTION Whether Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi Ghan Vati are effective in the management of Ardhavabhedaka (Migraine)? HYPOTHESIS NULL HYPOTHESIS : H0 -There is no effect of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi Ghan Vati in Ardhavabhedaka (Migraine). ALTERNATE HYPOTHESIS: H1 - There is significant difference in the effect of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi GhanVati in Ardhavabhedaka(Migraine). | |