| 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
|
|
|
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
|
|
|
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
|
|
|
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). |