| CTRI Number |
CTRI/2025/08/093805 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Hot and Dry Fomentation with Herbal Medicine in the Management of Plantar Fasciitis |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Takmeed e Muhallil (Hot and
Dry Fomentation with the Bundle of Specific Drugs) with Habb e
Suranjan Orally in the Management of Plantar Fasciitis (Waja al
Aqib) |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adeeba Noureen |
| Designation |
P.G. Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College 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 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9926414140 |
| Fax |
|
| Email |
adeebanaureen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehmooda Begum |
| Designation |
Professor and HOD |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College 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 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7000306293 |
| Fax |
|
| Email |
mehmoodaanzar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adeeba Noureen |
| Designation |
adeebanaureen@gmail.com |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College 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 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9926414140 |
| Fax |
|
| Email |
adeebanaureen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur 482003 Madhya Pradesh India |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Nill
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 Adeeba Noureen |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD 7 Department of Ilaj Bit Tadbeer and Female therapy Unit (Ground floor) and Physiotherapy unit
Second Floor Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
Bhopal
MADHYA PRADESH |
9926414140
adeebanaureen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim Syed Ziaul Hasan Unani Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Takmeede Muhallil (Hot and Dry Fomentation) Along with Habb -e Suranjan 2tab BD |
The procedure of Takmeede Muhallil to the test group will be carried out in Therapy Unit of Hakim Syed Zia-ul-Hasan Govt. Unani Hospital. First of all, the drugs (Bajra (Pennisetum glaucum)1part Saboos-e-Gandum (Triticum aestivum)1part Namak-e-Taam Table salt 1 part) to be used will be tied in a piece of cloth in shape of a potli (Bundle) and patient will be made in laying position. Then sesame oil will be applied on the surface of potli to facilitate the fomentation and it will be heated on the induction up to tolerable extent and will be applied on affected part. The duration of the procedure will be 10 to 15 mints per sitting. |
| Comparator Agent |
Therapeutic Ultrasound |
The Therapeutic Ultrasound will be carried out in Physiotherapy unit of the hospital with the help of Physiotherapist as per the SOPs. It will be applied on affected part for 10-15 minutes per sitting. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Plantar fasciitis with/without calcaneal spur
2. Patient fulfilling the inclusion criteria and agree to follow the protocol
3. plantar fasciitis without any surgical indication
4. Patients having no malignancy |
|
| ExclusionCriteria |
| Details |
1.Rheumatoid arthritis
2.Osteoporosis
3.Systemic diseases like inflammatory or degenerative polyarthritis, local or systemic infection, peripheral vascular diseases, metabolic disease, such as gout.
4.Pregnant patients
5.Previous treatment: Corticosteroid injection in the last 6 months or NSAIDs treatment within the last 7 day.
6.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 |
Visual Analogue Scale (VAS)
Lower Extremity Functional Scale (LEFS)
|
on 0, 7,14,21,28 and 35th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SF 12 (Quality of life)
Range of motion (Goniometer)
|
on 0, 7,14,21,28 and 35th day |
|
|
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)
|
08/09/2025 |
| 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
|
Takmeed e Muhallil Hot and Dry Fomentation with the Bundle of Specific Drugs with Habb e Suranjan Orally in the Management of Plantar Fasciitis Waja al Aqib is designed to assess the safety and effectiveness of these Unani treatments in patients with plantar fasciitis. The aims are to provide a safe effective and economical treatment for heel pain and to improve the quality of life of patients. The study will be conducted at Hakim Syed Ziaul Hasan Government Autonomous Unani Medical College and Hospital Bhopal over a duration of one year with therapy lasting thirty five days. Plantar fasciitis is a common cause of heel pain disability and poor quality of life particularly in middle aged women obese individuals and young male athletes. In Unani medicine it is described as Waja al Aqib a type of Waja ul Mafasil or joint pain. Traditional remedies such as Takmeed and Habb e Suranjan have been used for pain and inflammation but require scientific validation. This randomized open controlled study will recruit eligible patients after ethical clearance and informed consent. Pre treatment investigations including blood tests arthritis profile X ray and ultrasound of the foot will be done. The test group will receive Takmeed e Muhallil locally along with Habb e Suranjan orally while the control group will receive therapeutic ultrasound. Treatment will be given in multiple sittings over four weeks and patients will be followed up on days 7 14 21 28 and 35. Outcomes will be measured using Visual Analogue Scale Lower Extremity Functional Scale SF 12 quality of life and range of motion by goniometer. The inclusion criteria are patients aged 18 to 60 years with plantar fasciitis with or without calcaneal spur and without surgical indication or malignancy. Exclusion criteria include rheumatoid arthritis osteoporosis systemic arthritis infections vascular or metabolic diseases such as gout pregnancy and recent steroid or NSAID use. The total sample size will be 44 patients with 22 in each group. Temperament or Mizaj will also be assessed according to classical Unani parameters. Concomitant medications will be recorded but painkillers will only be permitted in urgent situations as rescue therapy. |