| CTRI Number |
CTRI/2025/03/082889 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| 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 study effect of Irrigation of head with extract of polyherbal formulation in Anxiety. |
|
Scientific Title of Study
|
Clinical study to evaluate the therapeutic efficacy of Natul(Joshanda of Shibt, Susan, Babuna and Nakhuna) in the management of Izterab-i-Nafsani Umoomi (Generalized Anxiety Disorder). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
Professor and HOD Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagr Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.SR@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
Professor and HOD Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagr Jammu and Kashmir
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.SR@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumeena |
| Designation |
PG Scholar Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagr Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006708360 |
| Fax |
|
| Email |
samgulzar786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine (CCRUM) New Delhi-110023, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM) University of Kashmir Naseem bagh Campus Srinagar, Pin code-190006, Jammu and Kashmir |
| Type of Sponsor |
Research institution and 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 Shameem Ahmad Rather |
Regional Research Institute of Unani Medicine (RRIUM) |
Moalajat OPD-1, Ground floor, Department of Moalajat, RRIUM, Naseem Bagh Campus, University of Kashmir Hazratbal Srinagar
Srinagar
JAMMU & KASHMIR |
7889584083
shameem.rather.SR@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM, Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Natul (Irrigation) Joshanda of Shibt, Susan, Babuna and Nakhuna |
Natul is a Unani Regimenal procedure in which decoction of medicines or hot water is poured on desired body part from a pre-fixed height for a predetermined period of time. The therapy is to be done alternatively for first 14 days (7 sittings) , then twice weekly for two weeks (4 sittings), followed by once weekly for two weeks (2 sittings) for 20 minutes for 42 days |
| Comparator Agent |
Tablet Sertraline 50mg |
Tab Sertraline 50mg once a day orally at bedtime for 42 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Clinically diagnosed patients of Izterab-i-Nafsani Umoomi.
2) Patients in age group of 18 to 65 years
3) All genders
4) Patients who are ready to sign the informed consent, follow the protocol and are willing to participate in clinical study voluntarily
|
|
| ExclusionCriteria |
| Details |
1) Panic disorder, obsessive-compulsive disorder, and post-traumatic stress disorder.
2) Patients below 18 years and above 65 years
3) History of substance abuse: Caffeine, Alcohol, drug intoxication
4) Patient who fails to follow up
5) Patient who fails to give written consent
6) Known cases of hyperthyroidism, cardiovascular diseases, renal diseases, and liver diseases.
7) Pregnant and lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hamilton Anxiety Rating Scale (HAM-A) |
42 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Vegetative manifestations (increased heart rate, diaphoresis, tremor, or dry mouth)
•Symptoms in the chest cavity (respiratory symptoms, feeling of tightness, chest pain, abdominal discomfort)
•Mental symptoms (dizziness, derealization, fear of losing control, fear of dying)
•General symptoms (hot or cold flashes, paresthesias)
•Symptoms of tension (muscle tension, agitation, foreign body sensation in throat)
•Other nonspecific symptoms (exaggerated startle response, lack of concentration, irritability, difficulty falling asleep)
|
42 Days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
10/04/2025 |
| 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="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
|
Anxiety defined as a subjective sense of unease, dread, or foreboding can indicate a primary psychiatric condition or can be a component of, or reaction to a primary medical disease. Anxiety disorders, the most prevalent psychiatric illnesses in the general community, are present in 15-20% of medical clinic patients. Generalized anxiety disorder (GAD) is characterized by persistent, excessive, and/or unrealistic worry associated with muscle tension, impaired concentration, autonomic arousal, feeling "on edge" with restlessness, and insomnia. The lifetime prevalence of GAD is 5-6%; the risk is higher in first-degree relatives of patients with the diagnosis. More than 80% of patients GAD also suffer from major depression, dysthymia, or social phobia. Primary anxiety disorders include Generalized Anxiety Disorder (GAD), Phobic disorders (social or specific), obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD). In Unani literature, there is description of Fikr (worry) which is used as synonym of Izterab-I-Nafsani. Literally Izterab-I-Nafsani stands for worry, excessive thinking, fear and hindrance in routine work.The description of anxiety disorders as such, is not found in Unani literature but their symptoms show a considerable overlap with other diseases, such as, like malankhuliya, waswas, maniya, sahr, hizyan, ishq and khafaqan etc. In malankhuliya, the mental functions of an individual are deranged leading to constant grief, fear, and dubious aggression. Modern management includes Cognitive behavioral therapy, deep muscle relaxation and drugs like Benzodiazepines, Selective Serotonin Receptor Uptake Inhibitors, Serotonin and Norepinephrine Reuptake Inhibitors and Beta Blockers, which are useful in short term, but long-term use can lead to dependence. Due to dependance, these drugs have many withdrawal symptoms like irritability, nausea, drowsiness, vomiting, nightmares, headache or paresthesias. On the other hand, Unani management includes use of Muqawwiyat (Tonics), Mufarrihat (Exhilarants) and Munaqqiyat (Evacuants) along with some effective regiminal therapies like Dalk (Massage), Natul (Irrigation), Suoot etc which work upon the principle of strengthening the essential organs and evacuation of morbid humor. In the current era of devastating effects on mental health, with the objective of improving the quality of life, a study entitled; clinical study to evaluate the therapeutic efficacy of Natul (joshanda of Shibt, Susan, Babuna and Nakhuna) in the management of Izterabi-I-Nafsani Umoomi (Generalized Anxiety Disorder) has been designed. |