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CTRI Number  CTRI/2026/02/102735 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 02/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Assessing the safety and benefits of a unani herbal medicine in patients with Post-stroke Depression 
Scientific Title of Study   Post Stroke Depression - A Parallel arm randomized placebo controlled clinical trial analyzing the biocompatibility and therapeutic potential of unani formulation Habb-e-aftimoon 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Khizra Fatima 
Designation  PG scholar  
Affiliation  GOVERNMENT NIZAMIA TIBBI COLLEGE AND HOSPITAL  
Address  Dept of Moalajat,OPD room no.1, new building, Governments Nizamia tibbi college and hospital,kotla Alijah,moghalpura,charminar,500002-India

Hyderabad
TELANGANA
500002
India 
Phone  7780286686  
Fax    
Email  fkhizra18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SA Khadir Hussaini  
Designation  Assistant professor  
Affiliation  Government nizama tibbi college and hospital  
Address  Dept of Moalajat,OPD room no.1, new building, Governments Nizamia tibbi college and hospital,kotla Alijah,moghalpura,charminar,500002-India

Hyderabad
TELANGANA
500002
India 
Phone  7780286686  
Fax    
Email  drsakhussaini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Khizra Fatima 
Designation  PG scholar  
Affiliation  Government nizama tibbi college and hospital  
Address  Dept of Moalajat,OPD room no.1, new building, Governments Nizamia tibbi college and hospital,kotla Alijah,moghalpura,charminar,500002-India

Hyderabad
TELANGANA
500002
India 
Phone  7780286686  
Fax    
Email  fkhizra18@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Government nizama tibbi college and hospital  
Address  Dept of Moalajat, Opd room no.1, new building, Governments Nizamia tibbi college and hospital,kotla Alijah,moghalpura,charminar,500002-India 
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 Khizra Fatima  Government Nizamia tibbi college and general hospital   Dept of Moalajat,OPD room no 1 new building Governments Nizamia tibbi college and hospital,kotla Alijah,moghalpura,charminar,500002-India
Hyderabad
TELANGANA 
7780286686

fkhizra18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, GNTC, Hyderabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HABB E AFTIMOON  INGREDIENTS: - 1.Aftimoon - Cuscuta reflexa - 20gms 2.Ghariqoon - Polyporus officinalis - 10 gms 3.Turbud - Operculina turpethum- 10 gms 4.Ustukhuddus - Lavandula stoechas 10 gms 5.Bisfayej - Polypodium vulgare 10 gms 6.Raughan-e-Zard - Ghee (pure) 200gms 7.Aab-e-Badiyan - Foeniculum vulgare - 1 litre 2 Tablets of 1.25g twice daily (5g per day) with water after meals. For 12 weeks  
Comparator Agent  PLACEBO  ROASTED WHEAT FLOUR 500MG CAPSULES BD FOR 12 WEEKS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients exhibiting mild-moderate depression as assessed by ICD 10 criteria of depression
2.Patients having single ischemic or hemorrhagic stroke documented by CT scan or MRI before enrollment
3.Patients having a history of stroke more than 3 months
4.Willing to sign the informed consent form 
 
ExclusionCriteria 
Details  1.Patients with Previous history of more than one episode of stroke.
2.Previous history of known psychiatric disorders.
3.Severe Aphasia.
4.Chronic Alcoholism
5.Uncontrolled hypertension and Diabetes mellitus
6.Pregnant and lactating mothers
7.Medical conditions like Epilepsy, Renal and Hepatic diseases 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Hamilton Depression Rating Scale (HDRS17) Score  FOLLOW UP :- fortnightly for 3 months ( 0, 14,,28,42,56,70,&84) 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters ( ICD-10 criteria)
Improvement in quality of life 
FOLLOW UP :- fortnightly for 3 months ( 0, 14,,28,42,56,70,&84) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   09/03/2026 
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 Applicable 
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  
 Post-stroke depression (PSD) is a prevalent neuropsychiatric complication, affecting up to one-third of stroke survivors, and is associated with impaired functional recovery, social isolation, diminished quality of life, suicidal tendencies, and considerable caregiver burden. Globally, stroke and depression are among the leading contributors to disability-adjusted life years. PSD has a reported prevalence of 25–79%, influenced by diagnostic criteria and patient selection. In Unani system of medicine, depression is not mentioned as an individual disease entity rather it is mentioned as a symptom or group of symptoms of Melancholy (Melancholia) in which the mental functions of the individual are deranged leading to constant grief, fear and dubious aggression, attributed to deranged black bile (ghair tabayi sauda) humor imbalance.Conventional pharmacotherapy, including SSRIs and TCAs, shows delayed onset, modest efficacy, and potential risk of stroke recurrence. Pathophysiology of PSD is multifactorial, involving decreased levels of monoamines, Increased neuro inflammation with dysregulation of hypothalamic - pituitary - adrenal axis, decreased neurotrophic support such as BDNF and glutamate mediated excitotoxicity. Habb e Aftimoon 5-10 g is considered to be therapeutically useful in malankhuliya and waswaas its actions are Munaqqi e dimagh (drugs clearing vitiated humour from brain) and Mulaiyin (laxative).
 
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