| CTRI Number |
CTRI/2024/07/070313 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the impact of amalaki patra and bandhujiva patra with ghee in hoarseness of voice due to strain |
|
Scientific Title of Study
|
Effect of amalaki patra and bandhujiva patra along with ghee in phonotrauma-induced hoarseness - An open-label RCT |
| 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 Mokana Ranee S |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kayachikitsa, Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Amritapuri, Clappana P. O.
Kollam
Kollam
KERALA
690525
India |
| Phone |
8903513516 |
| Fax |
|
| Email |
am.ay.p3kca22006@ay.students.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devipriya Soman |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kayachikitsa, Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Amritapuri, Clappana P. O.
Kollam
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
dr.devipriya@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devipriya Soman |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Kayachikitsa, Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Amritapuri, Clappana P. O.
Kollam
Kollam
KERALA
690525
India |
| Phone |
9495638076 |
| Fax |
|
| Email |
dr.devipriya@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690 525 |
|
|
Primary Sponsor
|
| Name |
Dr Mokana Ranree S |
| Address |
Department of Kayachikitsa,
Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Amritapuri, Clappana P. O.
Kollam - 690525
Kerala, 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 Mokana Ranee S |
Amrita School of Ayurveda |
Kayachikitsa OPD,
Amrita School of Ayurveda,
Amrita Vishwa Vidyapeetham
Amritapuri Campus
Amritapuri, Clappana P. O.
Kollam - 690525
Kerala, India
Kollam
KERALA |
8903513516
am.ay.p3kca22006@ay.students.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R490||Dysphonia. Ayurveda Condition: SVARABEDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | | 1) Vocal hygiene
2) Relative voice rest | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaki and bandhujiva patra churna, Reference: Chikitsamanjari Ch.9(Svarasada chikitsa)-Sloka 8), Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: Yes(details: -ghee (twice the quantity of churna)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Hoarseness of voice induced due to shouting, screaming, singing and prolonged speaking,
2)With or without acute non-infective laryngitis
3)Those who are willing to participate in the study and signed the informed consent form
|
|
| ExclusionCriteria |
| Details |
1)Organic lesions in vocal cord and oropharynx except vocal nodules,
2)Afflicted with common cold,
3)Productive cough,
4)Tonsillitis,
5)Goitre.
6)Inflammed cervical lymph nodes
7)Congenital voice disorders
8)Chronic smokers
9)Upper respiratory allergies to pollen & dust
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acoustic analysis software – PRAAT to measure shimmer, jitter, and HNR ratio |
Day 0 and day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GRBAS Scale for perceptual assessment of voice quality - rated by a qualified Speech Language Pathologist
|
Day 0 and day 6 |
| Voice handicap index (VHI) (English & Malayalam) |
Day 0 and day 6 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/07/2024 |
| Date of Study Completion (India) |
24/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 an open label double arm randomized controlled trial to study the effect of amalaki patra and bandhujiva patra churna along with ghee in phonotrauma-induced hoarseness in people of age 18 to 60 years old. The test group will be given 12 grams of amalaki patra and bandhujiva patra churna with ghee for 5 days. The control group will follow relative voice rest and vocal hygiene for 5 days. Null Hypothesis: The administration of amalaki patra and bandhujiva patra churna with ghee for 5 days, is not as effective as relative voice rest and vocal hygiene in changing the scores of acoustic parameters -jitter, shimmer and HNR as measured by PRAAT, GRBAS scale and VHI in individuals with phonotrauma-induced hoarseness of voice Alternative Hypothesis: The administration of amalaki patra and bandhujiva patra churna with ghee for 5 days, is more effective than relative voice rest and vocal hygiene in changing the scores of acoustic parameters -jitter, shimmer and HNR as measured by PRAAT, GRBAS scale and VHI in individuals with phonotrauma-induced hoarseness of voice. Primary objective: To acoustically analyse the jitter, shimmer, and HNR ratio of voice using PRAAT pre and post-test · To assess the GRBAS scale pre & post test · To assess the VHI scale pre & post test
|