A study to evaluate the effect of Thirumoolar Pranayamam as an add-on treatment with Kadukkai Karpam in the management of Viyagula Unmatham with special reference to Depression.

An open-labelled, double-arm, Phase II clinical trial to evaluate the effectiveness of Kadukkai Karpam and Kadukkai Karpam with Thirumoolar Pranayamam in the management of Viyagula Unmatham with special reference to Depression. - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085864

Enrollment

Registered

2025-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Kadukkai Karpam (Internal Medicine): Kadukkai karpam is powdered form of Kadukkai (Fruit of Terminalia chebula of Combretaceae family) Oral administration of 3 grams of medicine once

Eligibility

Inclusion criteria

Inclusion criteria: 1. Hamilton Depression Rating Scale (HAMD-17) score of 18 or more 2. Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 45 days but can opt out of the trial of his/her own conscious discretion.

Exclusion criteria

Exclusion criteria: 1. Any co morbid psychiatric illness especially bipolar depression, schizophrenia or dementia 2. Suicidal intent or any other psychiatric emergency 3. Evidence of other medical comorbidity that could substantially influence depression or has an effect on cognition and behavior 4. History of alcohol or drug abuse over the last 6 months 5. Anti-epileptic drugs 6. Pregnancy or Post-partum women. 7. Acute infectious diseases 8. Ongoing current practice of yoga or any other mind-body techniques. 9. Pre existing Cardiac illness, severe lung illness.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the trial will be reduction in depressive symptoms, assessed using a validated depression rating scale such as PHQ-9 questionnaire from baseline to the end of the intervention period.Timepoint: Baseline (0th day) and at the end of the intervention period (45th day)	—

Secondary

Measure	Time frame
This research explores the potential synergistic benefits of Thirumoolar Pranayamam as an addon intervention with Kadukkai Karpam in enhancing therapeutic outcomes of Viyagula Unmatham with special reference to depression.Timepoint: Baseline (0th day) and the end of the intervention period (45th day)	—

Countries

India

Contacts

Public ContactDr V Mahalakshmi MD Siddha

Government Siddha Medical College and Hospital, Palayamkottai

drmahalakshmi67@gmail.com8248818479

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026