Effects of Saffron and Chamomile in Mild to Moderate Depression

NCT04935671 | Unknown

• 1 other identifier: 0924
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes characterized by decreased production, or resistance to the action of insulin or both. The reduced production or action alters many important body functions namely glucose absorption and utilization in the body. The disturbed glucose metabolism profoundly effects transportation of large neutral amino acids especially tryptophan in brain leading decreased synthesis of serotonin and hence ensuing depression, memory loss and various other psycho-neurological problems. Different antipsychotic treatments like serotonin reuptake inhibitors, monoamine inhibitors and tricyclic antidepressants are available in the market to treat depression but are not devoid of adverse effects. Therefore, there is a tendency in underdeveloped countries to use alternative remedies to combat the psycho-neurological issues. Nature has bestowed the bounty of indigenous herbs like Saffron (Crocus sativusL) and chamomile (Matricaria chamomileL), that possess neuro-protective effects and are regularly consumed in day to day delicacies with no documented adverse-effects nor adverse events Though these herbs have been studied widely for their multiple therapeutic benefits, however, till date both of these herbs in combination have not been studied as an adjuvant therapy for mild to moderate depression. Therefore the present study is designed to determine the combined beneficial effects of these herbs as an adjuvant therapy for treatment of depression.

Conditions

Depression

Keywords

Depression; Diabetes; PHQ9; saffron; chamomile

Outcome Measures

Primary Outcomes (1)

• Depression

  100 participants with adjuvant therapy in Arm A (allopathic+herbal) and 100 participants of Arm B with allopathic treatment only will be assessed by PHQ 9 questionnaire before and after intervention through change in PHQ 9 score.

  1 month

Secondary Outcomes (3)

• Glucose

  1 month

• lipid profile

  1 month

• Tryptophan

  1 month

Study Arms (2)

Allopathic + Herbal

ACTIVE COMPARATOR

20mg of chamomile and 1 mg saffron in form of teabag for preparation of herbal decoction in dose of two teabags per day for a month as an "ADJUVANT THERAPY" with standard allopathic treatment for depression.

Dietary Supplement: chamomile tea n saffron

Allopathic only

NO INTERVENTION

Only allopathic medication for depression.

Interventions

chamomile tea n saffron DIETARY_SUPPLEMENT

20 mg of chamomile and 1 mg saffron in a teabag given twice daily for a month in combination with allopathic treatment for depression.

Allopathic + Herbal

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of mild to moderate depression
• tea bags for preparation of herbal decoction will be given as adjuvant therapy

You may not qualify if:

• cancer
• morbid depression

Sponsors & Collaborators

• Dr Saara (Ahmad) Muddasir Khan: lead
• University of Karachi: collaborator

Study Sites (1)

Aga Khan University

Karachi, PK, 74800, Pakistan

Location

MeSH Terms

Conditions

Depression; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blocked randomization technique has done via software
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study design will be prospective, randomized, open-labeled, blinded end-point trial for a period of 4-weeks.

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 23, 2021
• Study Start: January 1, 2020
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

PA (1)