DepressionNCT04935671
Effects of Saffron and Chamomile in Mild to Moderate Depression
A study testing chamomile tea n saffron in people with Depression, run by Dr Saara (Ahmad) Muddasir Khan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- chamomile tea n saffron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of mild to moderate depression
- tea bags for preparation of herbal decoction will be given as adjuvant therapy
Who cannot join
- cancer
- morbid depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-administration of Saffron and Chamomile: to Determine the Efficacy as an Adjuvant Therapy for Mild to Moderate Depression in Human Subjects
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.
Read the detailed description
Depression is a psychological state constellation of sad mood, agitation, lack of interest and feelings of worthlessness. Depression may be developed or aggravated by multiple factors like death of a loved one, unhealthy living environmental condition, seasonal variations and during postpartum state. It has been studied previously that the brain neurotransmitters, monoamines namely serotonin, dopamine and/or norepinephrine are altered in depression. The most notable monoamine that plays a vital role is serotonin also known as 5 hydroxy tryptamine (5- HT). The precursor of serotonin in brain is identified as tryptophan and its transport in brain declines leading to reduced synthesis of serotonin and hence ensuing depressive states. It is also noted that serotonin production is decreased profoundly in diabetic subjects. Insulin plays a vital role in mobilization of tryptophan into brain by facilitating transport of other large neutral amino acids in somatic compartments. Hence, insulin resistance or its deficiency leads to compromised access of tryptophan in the brain ultimately resulting in reduced production of serotonin causing depression.
Likewise the composition of diet consumed does have a major role in the mood alteration. Upon consumption of protein rich food, the concentrations of large neutral amino acids levels are increased in the blood. The competition between the large neutral amino acids and the tryptophan at the brain receptor level to cross the blood brain barrier increases leading to relatively lesser transport of tryptophan in the brain. On the other hand, food rich in carbohydrates in normo-glycemics causes increase sugar levels in the blood resulting in increased insulin secretion. The optimal level of insulin enhances the entry of large neutral amino acids in the body tissues leaving increased tryptophan to enter brain.
The prevalence of depression in the population Karachi, Pakistan is known to be 25- 30%. Different antipsychotic treatments like serotonin reuptake inhibitors, monoamine inhibitors and tricyclic antidepressants are commonly available in the market to treat anxiety and depression. Their principle action is mediated through alteration of the brain neurotransmitters levels, however, their short and/or long term administration may precipitate wide range of adverse effects including tolerance and habituation, insomnia, suicidal tendency and aggravation of depressive episodes. Therefore, there is a popular trend in developing countries to use alternative remedies for the treatment of psycho-neurological issues like depression and nature has bestowed the bounty of indigenous herbs that possess neuro-protective effects and may be used for medicinal purpose in population. Crocus sativusL. commonly known as Saffron and Matricaria chamomileL. referred as chamomile, have been used since ages for the diverse medicinal benefits such as fever, inflammation, muscle spasms, menstrual disorders, infertility, gastric ulcers, insomnia, depression, anxiety and dementia. These herbs are regularly consumed in day to day delicacies and have largely been found safe at tolerated dose ranges.
Saffron The main components of saffron are crocin, picrocrocin and safranal. The median lethal doses (LD50) of saffron are 200 mg/ml and 20.7 g/kg in vitro and in animal studies, respectively. Saffron has been suggested to be effective in the treatment of a wide range of disorders including coronary artery diseases, hypertension, stomach disorders, dysmenorrhea and depression, anxiety, learning and memory impairments. Saffron is reported to be effective for depression at 30mg/kg/oral dose or in two divided doses of 15 mg/kg body weight, while its higher doses (200-800 mg/kg body weight) administered orally were found to be effective for the treatment of epilepsy and Alzheimer's disease. Similarly, diverse dose-range has been used for the treatment of asthma, cough, hemoptysis, Alzheimer's disease, heart burn, infertility, PCOS, anti-inflammatory, anti-sclerotic as well as neuro-protective agent. Administration of saffron and its constituents increases glutamate and dopamine levels in the brain. It has also demonstrated antidepressant effects in clinical studies and extensive anxiolytic effects in experimental animal models.
Likewise, chamomile has also demonstrated neuro-protective and anxiolytic effects in the both human and animal model.
Chamomile The main components of chamomile are bisabolo. The median lethal doses (LD50) of chamomile are 15ml/kg. However, 1-2 ml/ kg of bisabolol can be well tolerated by rats. Chamomile has been found well found well tolerated up to the dose of 1500 mg/kg/day with no severe adverse effects. Chamomile is reported to be effective in the dose range from 30 mg/kd/day to 100mg/kg/day in form of ethanolic extract or water decoction. Different dose ranges are used for the treatment of various ailments like 9-15g/kg/day for respiratory infections, 30mg/kg/day to 100mg/kg/day for the treatment of eczema, skin infections, and Chrons disease, abdominal spasm, diarrhea, infertility, in post-menopausal states, respiratory and renal infections and inflammations as well as mood swings and anxiety. Several lines of evidence suggest that most of the flavonoid constituents of chamomile may produce anxiolytic activity by affecting γ-amino butyric acid (GABA), noradrenalin (NA), dopamine (DA), and serotonin neurotransmission or by modulating hypothalamic-pituitary-adrenocortical axis function.
Though there are studies are available in literature supporting the clinical efficacy of saffron or chamomile in anxiety or depression, there is no single study highlighting the potential benefits of co-administration of saffron and chamomile tea for the treatment of mild to moderate depression with or without co-morbid diabetes.
- Conditions
- Depression
- Being tested
- chamomile tea n saffron
- Keywords
- Depression, Diabetes, PHQ9, saffron, chamomile
- Medical subject headings
- Depression, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chamomile tea n saffronDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: chamomile tea n saffron |
| Allopathic only | No intervention | Only allopathic medication for depression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
Glucose
the concentration of glucose will be measured in all participants for normoglycemia (fasting glucose: 65-100mg/dl) before and after intervention.
Measured: 1 month
lipid profile
the concentration of lipids (serum cholesterol 200mg/dl, triglycerides <150mg/dl, HDL-cholesterol >40mg/dl, LDL-cholesterol<100mg/dl, VLDL-cholesterol <100mg/dl) will be measured in all participants before and after intervention.
Measured: 1 month
Tryptophan
the level of tryptophan (0.34-80 ng/mL) will be measured in all participants before and after intervention.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Jan 2020
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design will be prospective, randomized, open-labeled, blinded end-point trial for a period of 4-weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Saara (Ahmad) Muddasir Khan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Karachi
- Responsible party
- Sponsor-investigator, Dr Saara (Ahmad) Muddasir Khan, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935671
- Sponsor's protocol ID
- 0924
- Status last verified
- Sep 2023
- First submitted
- 31 May 2021
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-administration of Saffron and Chamomile: to Determine the Efficacy as an Adjuvant Therapy for Mild to Moderate Depression in Human Subjects
- ClinicalTrials.gov ID
- NCT04935671
- Acronym / sponsor ID
- 0924
- Conditions
- Depression
- Keywords
- Depression, Diabetes, PHQ9, saffron, chamomile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr Saara (Ahmad) Muddasir KhanUniversity, hospital or other
- Collaborators
- University of Karachi
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depression is a psychological state constellation of sad mood, agitation, lack of interest and feelings of worthlessness. Depression may be developed or aggravated by multiple factors like death of a loved one, unhealthy living environmental condition, seasonal variations and during postpartum state. It has been studied previously that the brain neurotransmitters, monoamines namely serotonin, dopamine and/or norepinephrine are altered in depression. The most notable monoamine that plays a vital role is serotonin also known as 5 hydroxy tryptamine (5- HT). The precursor of serotonin in brain is identified as tryptophan and its transport in brain declines leading to reduced synthesis of serotonin and hence ensuing depressive states. It is also noted that serotonin production is decreased profoundly in diabetic subjects. Insulin plays a vital role in mobilization of tryptophan into brain by facilitating transport of other large neutral amino acids in somatic compartments. Hence, insulin resistance or its deficiency leads to compromised access of tryptophan in the brain ultimately resulting in reduced production of serotonin causing depression.
Likewise the composition of diet consumed does have a major role in the mood alteration. Upon consumption of protein rich food, the concentrations of large neutral amino acids levels are increased in the blood. The competition between the large neutral amino acids and the tryptophan at the brain receptor level to cross the blood brain barrier increases leading to relatively lesser transport of tryptophan in the brain. On the other hand, food rich in carbohydrates in normo-glycemics causes increase sugar levels in the blood resulting in increased insulin secretion. The optimal level of insulin enhances the entry of large neutral amino acids in the body tissues leaving increased tryptophan to enter brain.
The prevalence of depression in the population Karachi, Pakistan is known to be 25- 30%. Different antipsychotic treatments like serotonin reuptake inhibitors, monoamine inhibitors and tricyclic antidepressants are commonly available in the market to treat anxiety and depression. Their principle action is mediated through alteration of the brain neurotransmitters levels, however, their short and/or long term administration may precipitate wide range of adverse effects including tolerance and habituation, insomnia, suicidal tendency and aggravation of depressive episodes. Therefore, there is a popular trend in developing countries to use alternative remedies for the treatment of psycho-neurological issues like depression and nature has bestowed the bounty of indigenous herbs that possess neuro-protective effects and may be used for medicinal purpose in population. Crocus sativusL. commonly known as Saffron and Matricaria chamomileL. referred as chamomile, have been used since ages for the diverse medicinal benefits such as fever, inflammation, muscle spasms, menstrual disorders, infertility, gastric ulcers, insomnia, depression, anxiety and dementia. These herbs are regularly consumed in day to day delicacies and have largely been found safe at tolerated dose ranges.
Saffron The main components of saffron are crocin, picrocrocin and safranal. The median lethal doses (LD50) of saffron are 200 mg/ml and 20.7 g/kg in vitro and in animal studies, respectively. Saffron has been suggested to be effective in the treatment of a wide range of disorders including coronary artery diseases, hypertension, stomach disorders, dysmenorrhea and depression, anxiety, learning and memory impairments. Saffron is reported to be effective for depression at 30mg/kg/oral dose or in two divided doses of 15 mg/kg body weight, while its higher doses (200-800 mg/kg body weight) administered orally were found to be effective for the treatment of epilepsy and Alzheimer's disease. Similarly, diverse dose-range has been used for the treatment of asthma, cough, hemoptysis, Alzheimer's disease, heart burn, infertility, PCOS, anti-inflammatory, anti-sclerotic as well as neuro-protective agent. Administration of saffron and its constituents increases glutamate and dopamine levels in the brain. It has also demonstrated antidepressant effects in clinical studies and extensive anxiolytic effects in experimental animal models.
Likewise, chamomile has also demonstrated neuro-protective and anxiolytic effects in the both human and animal model.
Chamomile The main components of chamomile are bisabolo. The median lethal doses (LD50) of chamomile are 15ml/kg. However, 1-2 ml/ kg of bisabolol can be well tolerated by rats. Chamomile has been found well found well tolerated up to the dose of 1500 mg/kg/day with no severe adverse effects. Chamomile is reported to be effective in the dose range from 30 mg/kd/day to 100mg/kg/day in form of ethanolic extract or water decoction. Different dose ranges are used for the treatment of various ailments like 9-15g/kg/day for respiratory infections, 30mg/kg/day to 100mg/kg/day for the treatment of eczema, skin infections, and Chrons disease, abdominal spasm, diarrhea, infertility, in post-menopausal states, respiratory and renal infections and inflammations as well as mood swings and anxiety. Several lines of evidence suggest that most of the flavonoid constituents of chamomile may produce anxiolytic activity by affecting γ-amino butyric acid (GABA), noradrenalin (NA), dopamine (DA), and serotonin neurotransmission or by modulating hypothalamic-pituitary-adrenocortical axis function.
Though there are studies are available in literature supporting the clinical efficacy of saffron or chamomile in anxiety or depression, there is no single study highlighting the potential benefits of co-administration of saffron and chamomile tea for the treatment of mild to moderate depression with or without co-morbid diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study design will be prospective, randomized, open-labeled, blinded end-point trial for a period of 4-weeks.
| Arm | Type | Receives |
|---|---|---|
| Allopathic + Herbal | Active comparator | Dietary Supplement: chamomile tea n saffron20mg 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. |
| Allopathic only | No intervention | –Only allopathic medication for depression. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of mild to moderate depression
- tea bags for preparation of herbal decoction will be given as adjuvant therapy
Key exclusion criteria (2 listed)
- cancer
- morbid depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chamomile tea n saffron20 mg of chamomile and 1 mg saffron in a teabag given twice daily for a month in combination with allopathic treatment for depression. | Dietary supplement | Allopathic + Herbal |
Primary outcome
Depression
Time frame: 1 month
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.
3 secondary outcomes
Glucose
Time frame: 1 month
lipid profile
Time frame: 1 month
Tryptophan
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chamomile tea n saffron in people with Depression, run by Dr Saara (Ahmad) Muddasir Khan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.