| CTRI Number |
CTRI/2026/03/105324 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of anxiety and depression (Malankhuliya) with Unani Medicine Habb-e-Ikhtilaj and Majoon-e Najah. |
|
Scientific Title of Study
|
Comparative Clinical Validation study of Unani Pharmacopoeial formulation Habb-e-Ikhtilaj vs Majoon-e Najah in Malankhuliya (Mixed Anxiety Depressive Disorder) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MK/MAAD/HI/MN/CLNVAL/CCRUM/23-24 version -01, 04.08.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Younis I Munshi |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
South West
DELHI
110058
India |
| Phone |
09419086700 |
| Fax |
|
| Email |
younismunshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:
1. Regional Research Institute of Unani Medicine- Plot No.38/39 , Sector-18 , Kharghar, Navi Mumbai-410210
2. Regional Research Institute of Unani Medicine- 1, West Meda Church Street, Royapuram, Chennai – 600013 |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farooqui Shazia Parveen |
Regional Research Institute of Unani Medicine |
Research OPD room Malankhuliya (Mixed Anxiety Depressive Disorder), 1, West Meda Church Street, Royapuram, Chennai – 600013
Chennai
TAMIL NADU |
8147438868
shaziafarooquinium@gmail.com |
| Dr Ziaurrahman |
Regional Research Institute of Unani Medicine |
Research OPD room Malankhuliya (Mixed Anxiety Depressive Disorder), Plot No.38/39 , Sector-18 , Kharghar, Navi Mumbai-410210
Mumbai
MAHARASHTRA |
8077530823
ziaur8898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of RRIUM, Chennai |
Approved |
| Regional Research Institute of Unani Medicine, Mumbai |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F413||Other mixed anxiety disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Ikhtilaj |
Two tablets (1 gm each) taken orally twice daily with water after meals for 6 weeks (42 days). |
| Comparator Agent |
Majoon-e-Najah |
5 gm taken orally twice daily with water after meals for 6 weeks (42 days). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically significant distress or impairment in social, occupational or other important areas of functioning.
2.Patients falling in the category of mild to moderate anxiety and depression-according to Hamilton rating scale.
3. Patients fulfilling the diagnostic criteria laid down by DSM-IV for MADD i.e. Patients with persistent or recurrent dysphoric mood lasting at least one month companied by four or more following symptoms for at least one month:
i. Fatigue or low energy
ii. Low self-esteem or feeling of worthlessness
iii. Difficulty concentrating or mind going blank
iv. Sleep disturbance (difficulty falling or staying asleep or restless, unsatisfying sleep
v. Being easily moved to tears
vi. Anticipating the worst
vii. Hopelessness
viii. Worry
ix. Hyper vigilance
x. Irritability
|
|
| ExclusionCriteria |
| Details |
1. Patients having severe anxiety or depression according to Hamilton rating scale (especially with suicidal ideation)
2. Drug abuser or any medication causing direct psychological effect.
3. Patient having past history of major depressive disorder (including an anxiety or mood disorder, in partial remission)
4. Presence of any mental disorder other than MADD.
5. Patients with diseases requiring long term treatment Known cases of hyperthyroidism, CVD, renal and liver diseases.
6. Severe anxiety or depression according to the Hamilton Rating Scale.
7. Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the signs and symptoms of Malankhuliya (Mixed Anxiety Depressive Disorder). Which will be assessed on the basis of Hamilton’s Anxiety rating scale and Hamilton’s Depression rating scale. |
At baseline, on 1st follow-up, 2nd follow-up and end of the protocol therapy. (i.e., 0, 2nd, 4th and 6th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline, on 1st follow-up and end of the protocol therapy. (i.e., 0, 2nd and 6th week) |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
14/03/2026 |
| 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="2"
Months="0"
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
|
This study is designed as a Multi centric, Randomized, Parallel Group, Active Controlled trial in patients with Malankhuliya (Mixed Anxiety Depressive Disorder) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks (i.e., 0, 2nd, 4th and 6th week). The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 6 weeks (42 days). Laboratory parameters for safety assessment will be conducted at baseline, first follow-up and on completion of the protocol therapy (i.e., at 0, 2nd and 6th week). Composition of Habb-e-Ikhtilaj:
|
S.
No.
|
Unani
Name
|
Botanical
Name
|
Weight
|
|
1
|
Turbud
|
Operculina turpethum L.
|
5 g
|
|
2
|
Aftimoon
|
Cuscuta reflexa Roxb.
|
2 g
|
|
3
|
Usara-e-Ghafis
|
Gentiana Olivieri Griseb.
|
500 mg
|
|
4
|
Usara-e-Afsanteen
|
Artemisia absinthium, Linn
|
500 mg
|
|
5
|
Shaham-e-Hanzal
|
Citrullus colocynthis
|
500 mg
|
|
6
|
Muqil
|
Commiphora mukul
|
500 mg
|
|
7
|
Anisoon
|
Pimpinella anisum L.
|
500 mg
|
|
8
|
Mastagi
|
Pistacia
lentiscus Linn
|
500 mg
|
|
9
|
Aab
|
-
|
Q.S.
|
Composition of Majoon-e-Najah:
| S. No. | Unani Name | Botanical Name | Weight | | 1 | Post-e-Halela Kabli | Terminalia chebula Retz. | 50 g | | 2 | Post-e-Balela | Terminalia belerica Roxb | 50 g | | 3 | Aamla | Emblica officinalis Gaertn. | 50 g | | 4 | Halela Siyah | Terminalia chebula Retz. | 50 g | | 5 | Turbud | Operculina turpethum (L) Silva Manso | 25 g | | 6 | Bisfayej | Polypodium vulgare L. | 25 g | | 7 | Aftimoon | Cuscuta reflexa L. | 25 g | | 8 | Ustukhuddus | Lavandula stoechas L. | 25 g | | 9 | Asl or Qand Safed | Apis mellifera L. | 600 g |
|