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CTRI Number  CTRI/2025/08/092896 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Unani
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of Efficacy and safety of steaming therapy and polyherbal formulation in the management of fibromyalgia 
Scientific Title of Study   Evaluation of Efficacy and Safety of Inkibab i Shabat (Steaming of Anethum graveolens) and Habbe Gule Aak in the Management of Fibromyalgia An Open Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tazeen Naved 
Designation  MD Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus Kolar bypass road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus Kolar Bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India 
Phone  9752795487  
Fax    
Email  drtazeennavedmd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ehsan Ahmed 
Designation  Assistant Professor 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus Kolar Bypass Road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus Kolar Bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India 
Phone  7354898786  
Fax    
Email  ehsan.azmi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tazeen Naved 
Designation  MD Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus Kolar Bypass Road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus Kolar Bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India 
Phone  9752795487  
Fax    
Email  drtazeennavedmd@gmail.com  
 
Source of Monetary or Material Support  
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur Madhya Pradesh, India 482001 
 
Primary Sponsor  
Name  Hakim Syed Ziaul Hasan Government Unani Medical Collegeand Hospital  
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh, India 462003 
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 Tazeen Naved  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital   OPD 7 Department of Ilaj bit Tadbeer (ground floor) female therapy unit (ground floor) and Physiotherapy unit(second floor) of Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal
Bhopal
MADHYA PRADESH 
9752795487

drtazeennavedmd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inkebab  The procedure of Inkibab to the test group will be carried out in Therapy Unit of Hakim Syed Zia ulHasan govternment Unani Hospital, Bhopal. The procedure will start as 50 grams of Anethum graveolens seeds (soya seeds) will be wrapped in a piece of cloth and will be soaked in 5 litres water for approximately 12 hours, thereafter it will be boiled in the same water till the steam is formed in an Autoclave like electric container which is tightly connected to a heat resistant LPG hose pipe through its pressure regulating device The pipe provides the passage to steam from the container to the affected body part Once the steam is ready to escape out the pipe the patient will be made in laying or sitting position whichever is suitable for him or her and steam will be applied on the affected part (tender points) from considerable distance by proper method 
Comparator Agent  Myofascial Release  The therapy will be done under the guidance of a physiotherapist on the effected site weekly for 12 sittings for 4 weeks in total, 6 sitting for 1st week (one daily), 3 sitting for 2nd week ( alternate days), 2 sittings for (3rd week on 3rd day) and 6th day, and one last sitting for 4th week on 6th day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group between 18 to 60,All Genders, Chronic pain complaint above 3 months ,Patient of fibromyalgia having no surgical indication, Patient having no malignancy, VAS pain score more than or equal to 6 in the two previous weeks, formal consent to study participation, Able to speak, read and understand english or hindi, Patient fulfilling the inclusion criteria and agree to follow the protocol. 
 
ExclusionCriteria 
Details  Patient with current diagnosis of infection or musculoskeletal inflammatory conditions, Use of NSAIDs ,opioids, anti depressants, betablockers in the 7 days before enrollment ,Chronic or acute pulmonary hematologic and kidney diseases, patient with confirm diagnosis of adrenal dysfunction , anemia, bone marrow disease, chronic fatigue syndrome, functional disorders, thyroid disorders, hypertension, diabetes mellitus, Lyme disease, multiple sclerosis, rheumatoid autoimmune disorders, spinal facet pain, vitamin and mineral deficiency, Patients with Active malignancy, Participation to other experimental studies in the month prior to the enrollment, Patients with Severe heart conditions or pacemaker, Chronic abuse of illicit drug and alcohol, Patients with Active Neuropsychiatric disorders, Females on oral contraceptive pills, Females in Menopausal Transition, Patient with permanent deformity, Patient having muscular contracture, Physiological state as pregnancy and lactation, Patients with history of trauma, Unwillingness or inability to comply the requirement of the protocol. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.VAS (visual analogue scale)
2.WPI (widespread pain index)
3.SSI (symptoms severity) index)
4.FIQR (revised fibromyalgia impacted questionnaire)
 
On day 0,7,14,21,28 and 35
 
 
Secondary Outcome  
Outcome  TimePoints 
SF12(Quality of life)  On day 0,7,14,21,28 and 35 
 
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)   20/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Fibromyalgia (FM) is a syndrome characterized by chronic widespread musculoskeletal pain at multiple tender points. It is characterized by joints stiffness, systemic symptoms like mood disorders, fatigue, anxiety, cognitive dysfunction (Fibro Fogg) and insomnia. The prevalence of FM is about 1-2%.It is highly female dominant disease accounting for 80–96%.FM generally appears in between 30-35 years. A subjective feeling of swelling without objective oedema, paresthesia, cognitive disorders, dizziness and weakness are also frequent symptom of the disease. The exact cause and pathophysiology of FM is still unknown, several factors like, dysfunction of central and autonomic nervous system, neurotransmitters, genetic predisposition, environmental exposure, hormonal factor and psychiatric aspect have been implicated in triggering FM.

In Unani classical literature, no disease is mentioned as Fibromyalgia, however its common symptoms such as Body ache, Restlessness, Mood disorder, Sleep disturbance and gut disturbance etc. and their treatments have been elaborated. So, FM is considered as Marz e Ghair Mudawwan (disease not mentioned in Unani literature). In such diseases which are not mentioned in the original text treatment is chosen on the basis of sign and symptoms. Unani system of medicine consists of three types of treatment methods; Ilaj bil Tadbir wal Taghziya (Regimenal and Dieto-therapy), Ilaj bil Dawa (Pharmacotherapy) and Ilaj bil Yad’(Surgery). Ilaj bil Tadbir includes several nonpharmacological or least pharmacological modalities, one of which is Inkebab. Anethum graveolens used as Inkebab is useful in the treatment of musculoskeletal problems. It is a therapeutic herb, grown all over the world, Its extract has analgesic,anti-inflammatory and smooth muscle relaxant action. Habbe Gule Aak (Unani polyherbal pill) is useful in treating musculoskeletal diseases and chronic pain because of its anti-inflammatory and analgesic action. and Control group is subjected to Myofascial Release (MFR).

 
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