| CTRI Number |
CTRI/2024/10/074947 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to evaluate the efficacy Of Mahamasha Oil Karanpooran(eardrops) and Syp.Mashabaladi Kwatha Orally in the management of Tinnitus |
|
Scientific Title of Study
|
A RANDOMISED CONTROL CLINICAL TRIAL TO EVALUATE THE EFFICACY OF MAHAMASHA TAILA KARNAPOORNA AND MASHBALADI KWATHA ORALLY IN THE MANAGEMENT OF KARNANADA/TINNITUS |
| 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 ASHU |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
|
| Address |
SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA HARYANA
Kurukshetra
HARYANA
136118
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHU |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
|
| Address |
SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA HARYANA
Kurukshetra
HARYANA
136118
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHLEKHA SHARMA |
| Designation |
Ph.D(SCHOLAR) |
| Affiliation |
saraswati ayurveda hospital and medical college Gharuan |
| Address |
HOUSE NO.2307 SECTOR 35 CHANDIGARH
Chandigarh
CHANDIGARH
160022
India |
| Phone |
9988306066 |
| Fax |
|
| Email |
sharmaashlekha@gmail.com |
|
|
Source of Monetary or Material Support
|
| SARASWATI AYURVEDIC HOSPITAL AND MEDICAL COLLEGE GHARUAN MOHALI PUNJAB PIN CODE;140413 INDIA |
|
|
Primary Sponsor
|
| Name |
DR ASHLEKHA SHARMA |
| Address |
SARASWATI AYURVEDIC HOSPITAL AND COLLEGE GHARUAN MOHALI PUNJAB INDIA PINCODE;140413 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 ASHLEKHA SHARMA |
SARASWATI AYURVEDIC HOSPITAL AND COLLEGE GHARUAN |
SARASWATI AYURVEDIC COLLEGE AND HOSPITAL GHARUAN MOHALI
Rupnagar
PUNJAB |
09988306066
sharmaashlekha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H931||Tinnitus. Ayurveda Condition: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MAHAMASHA TAILAM, Reference: BHAISAJYA RATNAVALI VAAT VYADHI ADHYAYE, Route: Otic, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: MASHABALADI QWATH, Reference: BHAISAJYA RATNAVALI VAAT VYADHI, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | CAP CAROVERINE | |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age of 16-65 years irrespective of age, sex, caste, religion etc.
2. Patients will selected on the basis of classical signs and symptoms of Karnanada (Tinnitus).
3. Subjective type of tinnitus.
4. Patients willing to be registered for trial. |
|
| ExclusionCriteria |
| Details |
1.Congenital deformity of external/middle ear
2.Blockage due to stenosis of external auditory canal/wax
3.Established diabetes mellitus and hypertension
4.Pregnant and lactating mothers.
5.Cases which required surgical intervention
7. Severe hearing loss and patients not fulfilling the inclusion criteria. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Based upon the
score of THI the classification of severity of tinnitus will be done:
THI SCORE BAND LEVEL OF TINNITUS
|
During the study of 60 days (Trial Treatment duration ) examination of the patient will be done
on 0th, 7th ,30th day and 60th day.
After completing the study of 60 days patient will be reassessed on 75th and
90th day.
Time period of study per patient – 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A. To access the safety profile of both the drugs.
B. To access the compliance of both the drugs
C. To compile & understand all the latest researches & treatments under trial for tinnitus |
Two months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
This is a self financed clinical trial.So no recruitment is required . I am Ph.D(SCHOLAR) In the field of ayurveda.I am conducting this trial to address a disease as well as a symptom called tinnitus.Ayurvedic interventions has many a times helped many times in cases of tinnitus.The drugs used here are in the form of eardrops as well as oral.Synergistic effect will be evaluated. |