| CTRI Number |
CTRI/2025/07/091421 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [drug] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of sleeplessness with Unani medicine |
|
Scientific Title of Study
|
Therapeutic evaluation of Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) in generalized anxiety disorder (GAD) associated insomnia.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMREEN SAYYED |
| Designation |
MD Scholar |
| Affiliation |
Jamia Hamdard University |
| Address |
Dept. of Moalajat, SUMER
Jamia Hamdard
South West
Delhi
110062
India
Dept. of Moalajat, SUMER
Jamia Hamdard
South West
Delhi
110062
India
South West
DELHI
110062
India |
| Phone |
9582848862 |
| Fax |
|
| Email |
dr.samreensayyed848862@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Wasi Akhtar |
| Designation |
Assisstant Professor |
| Affiliation |
Jamia Hamdard University |
| Address |
Dept. of Moalajat, SUMER
Jamia Hamdard
South West
Delhi
110062
India
Dept. of Moalajat, SUMER
Jamia Hamdard
South West
Delhi
110062
India
South West
DELHI
110062
India |
| Phone |
9027570265 |
| Fax |
|
| Email |
drmdwasiakhtar@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
SAMREEN SAYYED |
| Designation |
MD Scholar |
| Affiliation |
Jamia Hamdard University |
| Address |
Dept. of Moalajat, SUMER
Jamia Hamdard
South West
Delhi
110062
India
Dept. of Moalajat, SUMER
Jamia Hamdard
South West
Delhi
110062
India
South West
DELHI
110062
India |
| Phone |
9582848862 |
| Fax |
|
| Email |
dr.samreensayyed848862@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard (Deemed to be University),Mehrauli Badarpur road, New Delhi-110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard University |
| Address |
Jamia Hamdard University, Mehrauli Badarpur Road, near Batra Hospital, Block-D , Hamdard Nagar, New Delhi, Delhi-110062 |
| Type of Sponsor |
Other [Deemed to be university and Institutional hospital] |
|
|
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 Samreen |
Majeedia Unani Hospital, Jamia Hamdard |
OPD 11, Moalajat OPD, Majeedia Unani Hospital, Jamia Hamdard, New Delhi -110062
South West
DELHI |
9582848862
dr.samreensayyed848862@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tukhm-e-Kahu (Lactuca Sativa L.) |
3 gram powder of the drug in two equally divided doses orally, morning and evening for 28 days |
| Intervention |
Tukhm-e-Khurfa (Portulaca oleracea L.) |
3 gram powder of the drug in two equally divided doses orally, morning and evening for 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling Diagnostic Criteria of insomnia disorder and generalised anxiety disorder as per DSM 5-TR
2.Patients scoring 14+ on insomnia severity index (Clinical and Severe insomnia), and
3.Patients scoring upto 10 on GAD-7 scale (mild- moderate anxiety)
4.Mentally stable patients
5.Patient of all genders
6.Patients in age group of 18-65 years
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.Previous history of known psychiatric disorders except generalised anxiety disorder
3.Night shift workers
4.Excessive consumption of beverages having caffeine (tea, coffee or cola >5 cups or glasses per day)
5.Any concomitant medication for insomnia or anxiety
6.Patients having past history of seizures or epilepsy
7.Terminally ill, having any malignancy or chronic progressive medical or surgical condition
8.Patients having uncontrolled diabetes mellitus or hypertension
9.Patients of hyperthyroidism
10.Patients suffering from itching conditions like scabies, eczema and psoriasis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Insomnia Severity Score using Insomnia Severity Index (ISI) questionnaire.
2. Improvement in Generalised anxiety disorder score using GAD-7 questionnaire. |
Baseline,
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in clinical symptoms
1. mood uplifting
2. energy
3. public dealing |
Baseline,
4 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Background: Sleeplessness is a sign of both anxiety and depression, and depression is the most prevalent of these mental illnesses. Patients presenting with comorbid insomnia and anxiety, treatment for insomnia may be the most efficient treatment strategy. Although benzodiazepines are commonly used for chronic insomnia and anxiety, but they can have serious side effects, such as drowsiness, addiction, falls, fractures and cognitive impairment etc. While on other hand Unani medicine has the potentials to treat insomnia and anxiety without any known adverse effects. Despite the strong correlation between insomnia and anxiety disorder, there is relative lack of integrative treatment approaches and protocols that address both insomnia and anxiety simultaneously. Therefore, we have selected two Unani drugs namely Tukhm-e- Khurfa siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) to assess their comparative efficacy in the treatment of insomnia and anxiety. Objectives of the study: Primary Objective: To evaluate the therapeutic efficacy and safety of Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) in Generalized Anxiety Disorder (GAD) associated insomnia. Secondary Objective: To compare the therapeutic efficacy and safety of Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) in Generalized Anxiety Disorder (GAD) associated insomnia Interventions: Group A: 3 grams Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and Group B: 3 grams Tukhm-e-Kahu (Lactuca sativa L.) per day in capsule form in two divided doses for 4 weeks. Expected Outcome: Improvement in sleep quality and quantity (Improvement in Insomnia Severity Index—ISI) Improvement in GAD symptoms, (Reduction in GAD-7 Score) |