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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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