| CTRI Number |
CTRI/2025/03/081970 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the combined effect of Pathyaksha dhathryadi kashaya internally and Kushtadi lepam in tension type headache |
|
Scientific Title of Study
|
Combined effect of pathyaksha dhathryadi kashaya internally and kushtadi lepam in tension type headache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhagyasree B |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda college Kannur |
| Address |
Government Ayurveda College
Pariyaram
Kannur
Kerala
Kannur
KERALA
670503
India |
| Phone |
09496888353 |
| Fax |
|
| Email |
drbhagyasreenishanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VKV Balakrishnan |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Government Ayurveda College
Pariyaram
Kannur
Kerala
Kannur
KERALA
670503
India |
| Phone |
9447037892 |
| Fax |
|
| Email |
baluvkv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhagyasree B |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda College Kannur |
| Address |
Government Ayurveda College
Pariyaram
Kannur
Kerala
Kannur
KERALA
670503
India |
| Phone |
09496888353 |
| Fax |
|
| Email |
drbhagyasreenishanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College hospital Kannur |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyasree B |
| Address |
Government Ayurveda College
Pariyaram
Kannur Kerala |
| 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 |
| Bhagyasree B |
Government Ayurveda CollegeHospital Kannur |
Government Ayurveda College
Pariyaram
Kannur
670503
Kannur
KERALA |
09496888353
drbhagyasreenishanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda College Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: SIROROGAH/SIRAHSULA/SIRASTAPA/SIROBITAPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyaksha dhathryadi kashaya, Reference: sarangadhara samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -guda), Additional Information: - | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: sarangadhara samhitha, Procedure details: lepa choorna made into paste with ghee applied to forehead with a thickness of 5mm)
(1) Medicine Name: Kushtadi lepam, Reference: Ashtanga hridaya, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1]Age group in between 18-40 years irrespective of gender
2]Patients fulfilling the ICHD-3 diagnostic criteria of tension type headache
3]Patients who are willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
1]Patients with other types of headache
2]Pregnant and lactacting women
3]Subjects suffering from other systemic illness
4]Infrequent episodic type of tension headache |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| severity of pain assessed using visual analogue scale |
assessment will be done on 0th,15th ,45th and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reducing frequency and duration of pain |
assessment will be done on 0th,15th ,45th and 60th day |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
01/04/2025 |
| 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="0"
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
|
In the general population, tension type headaches, [TTHs], are the most common type of primary headache. It is characterized by bilateral, recurrent, mild to moderately intense headaches that feel tight or pressing and do not become worse with normal routine activities. TTH shares certain features of vatika sirasoola and kaphaja sirasoola mentioned in ayurvedic classics. Pathyaksha dhathryadi Kashaya and kushtadi lepa are two important ayurvedic formulations explained in classics that are beneficial in the management of shirasoola..Tension type headache [TTH] is highly prevalent with a life time prevalence rates varying across the studies between 30-78%, significally impacting socio -economic condition. The causes of TTH include stress, anxiety, tiredness, dehydration, bright light,noise, certain smell, sleep deprivation, uncomfortable position, bad posture, irregular feeding time, and constant use of mobile phone which causes excessive strains the eyes. This study aims to evaluate combined effect of Pathyaksha dhathryadi Kashaya internally and kushtadi lepam externally to reduce the intensity of pain as well as its recurrence |