| CTRI Number |
CTRI/2025/08/093249 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study effect of Rasnadyo Guggulu in ardhavabhedaka(simple migraine) |
|
Scientific Title of Study
|
A randomized controlled clinical trial to study the effect of Rasnadyo Guggulu in the management of ardhavabhedaka with special reference to simple 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 Prajakta Pundalikrao Akate |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
OPD NO 16 Shalakyatantra Department, SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA
422403
India |
| Phone |
7972977021 |
| Fax |
|
| Email |
prajaktaakate272@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siradram Gurubasappa Vagadurgi |
| Designation |
Reader |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
OPD NO 16 Shalakyatantra Department, SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9970638273 |
| Fax |
|
| Email |
Vagadurgi.eye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siradram Gurubasappa Vagadurgi |
| Designation |
Reader |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
OPD NO 16 Shalakyatantra Department, SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9970638273 |
| Fax |
|
| Email |
Vagadurgi.eye@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalakyatantra, SMBT Ayurved College and Hospital, Dhamngaon, Igatpuri Nashik 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Pundalikrao Akate |
| Address |
OPD no 16, Department of shalakyatantra, SMBT Ayurved college and Hospital Nandi Hills Dhamangaon Igatpuri Nashik Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 Prajakta Pundalikrao Akate |
SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403 |
OPD NO 16 Shalakyatantra Department, SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri Nashik 422403
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
7972977021
prajaktaakate272@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G430||Migraine without aura. 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: Rasnadyo Guggulu, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: -Rasnadyo Guggulu gutika 300 mg after meal | | 2 | Comparator Arm (Non Ayurveda) | | - | Cffeine Ergotamine tablets | 1 mg caffeine and 100 mg ergotamine tablet orally OD | | 3 | Comparator Arm (Non Ayurveda) | | - | Cffeine Ergotamine tablets | 1 mg caffeine and 100 mg ergotamine tablet orally OD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
a)Patients having lakshanas of ardhavabhedaka or simple migraine
b)Patients between age group og 18 to 60 years
c)patients will be included irrespective of sex, religion and caste |
|
| ExclusionCriteria |
| Details |
a)Patients with complicated migraine/hemiplegic migraine
b)patients age below 18 years and above 60 years
c)patients having a history of head trauma and other types of headaches
d)patients having any inflammatory diseases in nose, PNS, eyes and tears
e)patients suffering from other diseases like HIV, DM, HTN, pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of ardhavabhedaka after taking rasnadyo guggulu |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| where the trial group stands in comparison with control group in reduction with sign and symptoms of ardhavabhedaka |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
29/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Ayurveda has given prime importance to Shira where the Prana i.e. life exists. Acharya Charaka considered Shira as the supreme important and major part of the body which is known as Uttamang. Ardhavabhedaka is a Shiroroga which is mentioned in multiple literature of Ayurveda. Usually there is radiating and throbbing pain in head in Ardhavabhedaka. It is sadhya type of Shiroroga . Ardha means half side of the head and Bhedaka means perforating type of pain it is the disease having symptoms of Uttamanga ardhabhaga sambhedana toda, bhrama Rasnadyo Guggulu is the drug which is Shiroroghar. Therefore, it can be used to treat Ardhavabhedaka. It contains rasna, guggulu, devdaru, guduchi, suntha, eranda. Individually have various guna like vataghna, pittaghna, kaphaghna, shulaghana, tridoshaghna which when taken together will definitely found to be beneficial in treating ardhavabhedaka, so rasnadyo guggulu can be used as best alternative to caffeine ergotamine tablets.
Inclusion criteria a)Patients having Lakshanas of Ardhavabhedaka or simple migraine. b)Patients between age group of 18-60 years. c)Patients will be included irrespective of sex, religion and caste.
B]Exclusive criteria: a) Patients with complicated migraine, hemiplegic migraine. b) Patients age below 18 years and above 60 years. c)Patients having a history of head trauma and other types of headaches. d) Patients having any inflammatory diseases in nose ,PNS ,eyes and ears. e) Patients suffering from other diseases like HIV,DM,HTN, pregnant women . Patient will be selected from signs and symptoms mentioned in classical texts and are selected irrespective of sex, socioeconomic status and community, written consent from patient will be taken to prior to study. Computerised generated sampling technique will be used. Total 70 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (control group). Rasnadyo guggulu Group A (trial group) with dose 300 mg equivalent to dose 1 mg caffeine and 100 mg ergotamine tablet Group B (Control group) once a day will be given to patients. Both drugs will be administered in tablet form for 15 days. Observations will be done on day 0 day, 5th day, 10th day and 15th day and follow up on 31st day. Result of study will be drawn on the basis of criteria of assesment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased |