| CTRI Number |
CTRI/2024/10/074682 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effects of a polyherbal Unani formulation with standard control in the management of Generalized Anxiety Disorder |
|
Scientific Title of Study
|
A Clinical Study on Generalized Anxiety Disorder and its Management
with a Polyherbal Unani Formulation- A Randomized Standard Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shumaila saifi |
| Designation |
P G Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol Bagh, New Delhi
Central DELHI 110005 India |
| Phone |
9582284327 |
| Fax |
|
| Email |
shumailasaifi94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Naseem Akhtar Khan |
| Designation |
Professor and Supervisor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol Bagh, New Delhi
Central DELHI 110005 India |
| Phone |
9810815997 |
| Fax |
|
| Email |
drkhannaseem.akhtarkhan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shumaila saifi |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol Bagh, New Delhi-110005
Central DELHI 110053 India |
| Phone |
09582284327 |
| Fax |
|
| Email |
shumailasaifi94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, ajmal khan road, karol bagh, New Delhi-110005, India |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol Bagh, New Delhi-110005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shumaila saifi |
Ayurvedic and Unani Tibbia College and Hospital |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol Bagh, New Delhi-110005, India Central DELHI |
9582284325
shumailasaifi94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aqueous Extracts of Asgandh
(Withania somnifera)90mg, Tagar (Valeriana wallichii)30mg , Aftimoon (Cuscuta reflexa)60 mg, Bandranjboya
(Melissa parviflora)50mg, Bisfayij (Polypodium vulgare)50 mg, Sankhaholi (Evolvulus alsinoides)100mg,
Sumbulutteeb (Nardrostachys jatamansi)50mg, Kahu (Lactuca sativa) 60mg and Filfil siyah (Piper nigrum)10mg, filled in capsules. |
One capsule of 500 mg each twice daily after breakfast and dinner with
plain water for 2 months. |
| Comparator Agent |
Escitalopram oxalate
10 mg in Tablet form. |
1 tablet once daily after the
breakfast. for 2 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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 Outcome
|
| Outcome |
TimePoints |
To evaluate the effects of Unani Polyherbal Formulation on the Quality of life of the patient
of GAD. |
Assessment of Quality of life of patient at baseline and at the end of the study. |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
10/10/2024 |
| 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 Yet Recruiting |
| 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
|
This study is a randomized, parallel group, active controlled clinical trial to evaluate the safety and efficacy of the aqueous extract form of a Unani polyherbal formulation in the management of Generalized Anxiety Disorder and to compare its efficacy with standard drug by using modern scientific parameter. The study will also be used to study the effects of the polyherbal formulation on quality of life of the patient. Anxiety disorders are among the most common of all psychiatric disorders throughout the world. An increase in global anxiety prevalence has a significant threat to the population’s well-being and quality of life. Conventional treatment for anxiety in Allopathic System of medicine include the Benzodiazepines, Antidepressants and Azapirones etc. They are useful for the short-term treatment of anxiety. However, regular long-term use carries a very high risk of tolerance and dependence. These drugs are associated with a wide range of adverse effects such as, sedation, mental confusion & weakness, impaired psychomotor performance, palpitation etc. In Unani System of Medicine, several drugs have been reported to have beneficial effects in anxiety disorders and are in clinical practice for a longer period of time. However, the safety and efficacy of these drugs have not been evaluated and documented on scientific parameters. Hence, there is a need to develop a safe, efficacious, and economical drug from the herbal treasury of Unani medicine for the treatment of Generalized Anxiety disorder. The purpose of this study is to provide a safe, efficacious and economical drug for the management of Generalized Anxiety Disorder and to compare its efficacy with standard drug. |