| 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
|
|
|
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
|
|
|
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). |