| CTRI Number |
CTRI/2025/03/081970 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2026 |
| 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)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
26/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. This pre and post interventional study included 31 participants aged between 18 and 40 years diagnosed with tension type headache based on ICHD-3 criteria. Participants were administered Pathyakshadhathryadi Kashaya 48 ml twice daily with guda for 14 days. Kushtadi Lepam prepared with ghee was applied over the forehead once daily for 14 days. Assessment was carried out at baseline, after treatment, and during follow-up using headache severity assessed by Visual Analogue Scale (VAS), Frequency of headache, Duration of headache assessed by subjective grading. Statistical analysis was performed using Friedman test and Wilcoxon signed rank test. The study showed statistically significant improvement in headache severity, frequency, and duration after treatment (p < 0.001). The combined therapy demonstrated significant clinical efficacy in reducing the severity frequency and duration of tension type headache and improved the overall quality of life of participants. The combined administration of Pathyakshadhathryadi Kashaya internally and Kushtadi Lepam externally showed significant effectiveness in the management of tension type headache. The treatment protocol was found to be safe, economical, and beneficial in reducing headache severity,frequency and duration
|