To compare the effects of a polyherbal Unani formulation with standard control in the management of Generalized Anxiety Disorder

A Clinical Study on Generalized Anxiety Disorder and its Management with a Polyherbal Unani Formulation- A Randomized Standard Controlled Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074682

Enrollment

Registered

2024-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: F411- Generalized anxiety disorder

Interventions

Intervention1: Aqueous Extracts of Asgandh (Withania somnifera)90mg, Tagar (Valeriana wallichii)30mg , Aftimoon (Cuscuta reflexa)60 mg, Bandranjboya (Melissa parviflora)50mg, Bisfayij (Polypodium vulg

Eligibility

Inclusion criteria

Inclusion criteria: 1.Clinically diagnosed patients of Generalized Anxiety Disorder based on DSM-V criteria. 2.Patients in the age group of 18 to 65 years, irrespective of gender. 3.Patients, who are ready to sign the informed consent, follow the protocol and willing to participate in clinical study voluntarily.

Exclusion criteria

Exclusion criteria: 1.Patients unwilling to sign consent. 2.Patients with Anemia. 3.Pregnant and lactating women. 4.History of substance abuse: caffeine, alcohol, drug intoxication, smoking, tobacco chewing. 5.Patients with Panic disorder, Obsessive Compulsive disorder, Post-traumatic stress disorder. 6.Patients with thyroid disorders and other endocrine disorders. 7.Known cases of secondary hypertension, malignancy and hepato-renal insufficiency.

Design outcomes

Primary

Measure	Time frame
1.To assess the safety and efficacy of the proposed Unani Polyherbal Formulation in the treatment of generalized anxiety disorder on scientific parameters. 2.To compare the results of Polyherbal Unani Formulation with the standard control in the treatment of GAD in respect of safety and efficacy.Timepoint: 1.To evaluate safety -Haemogram, LFT, KFT at base line, 1st week and at the end of the study. and after 6 weeks. 2.To evaluate efficacy through assessment of subjective parameters at base line, and then weekly upto 8th week.	—

Measure

Time frame

1.To assess the safety and efficacy of the proposed Unani Polyherbal Formulation in the treatment of generalized anxiety disorder on scientific parameters. 2.To compare the results of Polyherbal Unani Formulation with the standard control in the treatment of GAD in respect of safety and efficacy.Timepoint: 1.To evaluate safety -Haemogram, LFT, KFT at base line, 1st week and at the end of the study. and after 6 weeks. 2.To evaluate efficacy through assessment of subjective parameters at base line, and then weekly upto 8th week.

—

Secondary

Measure	Time frame
To evaluate the effects of Unani Polyherbal Formulation on the Quality of life of the patient of GAD.Timepoint: Assessment of Quality of life of patient at baseline and at the end of the study.	—

Countries

India

Contacts

Public ContactShumaila saifi

Ayurvedic and Unani Tibbia College and Hospital

drkhannaseem.akhtarkhan@gmail.com9810815997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026