CTRI

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CTRI Number

CTRI/2026/04/107813 [Registered on: 07/04/2026] Trial Registered Prospectively

Last Modified On:

02/04/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Preventive

Study Design

Single Arm Study

Public Title of Study

To evaluate effect of ayurveda medicine and pranayama on voice fatigue in proffessional voice users.

Scientific Title of Study

A study on combined effect of yashtimadhuchoornam and bhramari Pranayama on functional dysphonia among voice professionals

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Cigi V S
Designation	PG Scholar
Affiliation	Government Ayurveda college,Tripunithura
Address	Department of Swasthavritta, Government Ayurveda Medical College, Dhanvantri Nagar, Puthiyakavu, Trippunithura, Ernakulam KERALA 682301 India
Phone	9446021387
Fax
Email	cigivs@gmail.com

Details of Contact Person
Scientific Query

Name	DrJayanD
Designation	HOD
Affiliation	Government Ayurveda college,Tripunithura
Address	Department of Swasthavritta Government Ayurveda College Tripunithura Ernakulam KERALA 682301 India
Phone	9447104383
Fax
Email	dr.jayan.d@gmail.com

Details of Contact Person
Public Query

Name	DrJayanD
Designation	HOD
Affiliation	Government Ayurveda college,Tripunithura
Address	Department of Swasthavritta Government Ayurveda College Tripunithura Ernakulam KERALA 682301 India
Phone	9447104383
Fax
Email	dr.jayan.d@gmail.com

Source of Monetary or Material Support

nil

Primary Sponsor

Name	Cigi VS
Address	PG Scholar, Department of Swasthavritta, Government Ayurveda Medical College, Dhanvantri Nagar, Puthiyakavu, Trippunithura, Ernakulam, Kerala, India- 682301
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Cigi V S	Government Ayurveda College Tripunithura	Department of Swasthavritta 4th floor,Hospital building 682301 Tripunithura Ernakulam KERALA	09446021387 cigivs@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE (IEC),Government Ayurveda College Tripunithura	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

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	Intervention Arm	Drug	Classical		(1) Medicine Name: yashtimadhu, Reference: Ashtanga hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -along with Bramari pranayama 10 mts daily for one month.

Inclusion Criteria

Age From	25.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Professional voice users who are diagnosed with functional dysphonia without other serious systemic illness. 2.Working hours of the participant should be more than 3.5 hours. 3.Who have given written and informed consent for the study.

ExclusionCriteria

Details

1. Pregnant women and lactating mothers.
2. Known case of malignancies.
3. Patients with history of DM.
4. Known cases of severe systemic illness like renal failure, cardiac failure and liver failure.
5. Working hours less than 3.5 hours.
6. Those who have GERD, peptic ulcer.
7. Those who undergoing speech therapy,
8. Those having vocal cord nodules.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To find the combined effect of yashtimadhu choornam with honey along with bhramari pranayama on functional dysphonia on professional voice users based on Voice Handicap Index (VHI)	1 month

Secondary Outcome

Outcome	TimePoints
To reduce the relapse of dysphonia assessed via follow ups.	3 month

Target Sample Size

Total Sample Size="21"
Sample Size from India="21"
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)

16/04/2026

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 Applicable

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

Functional dysphonia is a clinical condition characterized by hoarseness breathiness or voice loss occuring without any structural or neurological laryngeal pathology.Since it effect the livelihood of voice professional it is a serious condition.Existing treatment include voice rest and voice therapy.No treatment available to nourish and strengthen the vocal cords .This study is a humble attempt to find the effect of yashtimadhu choornam 2 gm with honey and bhramari pranayama 10 mts daily for a period of one month can bring relief to functional dysphonia .

This is a single arm pre post intervention study.Participants are patients with mild moderate functional dysphonia having VHI index upto 60 between age 25 and 60 who come to Government Ayurveda College Swasthavritta OP.Laryngoscopy will be performed for required patients under Dr.Sreekumar Co Guide Associate Proffessor Department of Salakyatantra Government Ayurveda College Tripunithura.Effect of study is evaluated using VHI Index Score.Study period is one month and follow up is done for 3 months to study the relapse .