| CTRI Number |
CTRI/2026/01/100679 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| 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
|
A study in adults testing a unani formulation to evaluate its safety and effectiveness in treating Rheumatoid arthritis |
|
Scientific Title of Study
|
A randomized parallel group, open labelled active controlled clinical study to evaluate the safety and efficacy of habb-e-hindi in the management of waja-ul- mafasil murakkab (rheumatoid arthritis) |
| 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 Mede Ramesh |
| Designation |
P G Scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
Government Nizamia Tibbi College, Kotla Alijah, Moghalpura, Charminar, Hyderabad, Telangana-500002-India.
Hyderabad
TELANGANA
500002
India |
| Phone |
9441994209 |
| Fax |
|
| Email |
drramesh1437@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammed Ahsan Faroqui |
| Designation |
Professor and H O D |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
Government Nizamia Tibbi College, Kotla Alijah, Moghalpura, Charminar, Hyderabad, Telangana-500002-India.
Hyderabad
TELANGANA
500002
India |
| Phone |
9849139356 |
| Fax |
|
| Email |
drfaroqui@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mede Ramesh |
| Designation |
P G Scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
Government Nizamia Tibbi College, Kotla Alijah, Moghalpura, Charminar, Hyderabad, Telangana-500002-India.
Hyderabad
TELANGANA
500002
India |
| Phone |
9441994209 |
| Fax |
|
| Email |
drramesh1437@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and Hospital,Kotla Alijah , Moghalpura, Charminar,Hyderabad,Telangana,500002-india. |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College |
| Address |
Government Nizamia Tibbi College, Kotla Alijah, Moghalpura, Charminar, Hyderabad, Telangana-500002-India. |
| 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 Mede Ramesh |
Government Nizamia Tibbi College and Hospital |
OPD and IPD of Government Nizamia Tibbi College and Hospital,Green Building Room no.122.
Hyderabad
TELANGANA |
9441994209
drramesh1437@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutonal Ethics committee,GNTC,Hyerabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M068||Other specified rheumatoid arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb E Hindi |
Habb E Hindi
Dosage form: tablet
Dose: 2.5 g bid with water after meals for 60 days with 4 follow ups at interval of 15 days
Composition of Unani Formulation Habb E Hindi:
1 Suranjan sheeren (Colichum luteum baker)
2 Badang babli (Ebelia ribes)
3 Zanjabeel (Zingiber officinale )
4 Muqil (Commiphora Wightii)
5 Asgandh (Withania somnifera)
6 Bozidan (Tanacetum umbelliferum)
7 Badhara (Sterospermum savelens)
8 Mosli safed (Chlorophytum borivilianum)
9 Sheetraj (Plumbago zeylanica)
10 Mirch e siyah (Piper nigrum)
11 Zeera siyah ( Cuminum cyminum)
12 Maweez munaqqah (Vitis vinifera) |
| Comparator Agent |
Tab Baricitinib |
Tab Baricitinib
Dose: 4 mg OD daily after meal
Duration: 08 weeks
Mode of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group above 18 to 60 years
sex: Both
RA factor positive
ACPA positive
ACR 2010 Criteria more than 6
|
|
| ExclusionCriteria |
| Details |
Other joint diseases,Patient with uncontrolled HTN, DM, CVS, Hepatic, Renal, Pulmonary diseases,Pregnant and lactating women,Drug or Alcohol addicts,H/o Intra articular corticosteroids drugs,Other Autoimmune diseases
|
|
|
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 |
| Change in DAS 28 Score from baseline to 2nd,4th,6th and 8th week post treament |
Change in DAS 28 Score from baseline to 2nd,4th,6th and 8th week post treament |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in ESR,RA factor,ACPA,CBP,LFT,KFT From baseline to 4th week and 8th week
|
Changes in ESR,RA factor,ACPA,CBP,LFT,KFT From baseline to 4th week and 8th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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
|
Rheumatoid Arthritis (RA) is a chronic, progressive, systemic autoimmune disorder characterized by symmetrical inflammatory polyarthritis, predominantly affecting the small joints of the hands and feet, leading to persistent pain, stiffness, swelling, and progressive joint deformities. In Unani medicine, the condition is described as Waja-ul-Mafasil Murakkab, which is believed to result from an abnormal mixture and imbalance of the humours—Balgham (phlegm), Safra (yellow bile), and Sawda (black bile)—often aggravated by cold temperament, poor digestion, excessive intake of unsuitable foods, and lack of physical activity. The prevalence of RA worldwide is estimated between 0.3–1% of the adult population, with nearly 18 million individuals affected globally, and in India the prevalence stands at approximately 0.75% as per ACR criteria. The disease exhibits a marked female predominance with a ratio of 3:1, and about 70% of the affected population consists of women, particularly between the ages of 40–70 years, where onset is most common. For the present clinical evaluation of Habb-e-Hindi, the inclusion criteria include adult patients aged 18–60 years of either sex, those who test positive for Rheumatoid Factor and Anti-Citrullinated Peptide Antibody (ACPA), and individuals fulfilling the ACR 2010 diagnostic criteria with a score of six or more. Exclusion criteria involve patients with other joint diseases, uncontrolled hypertension, diabetes mellitus, cardiovascular, renal, pulmonary, or hepatic diseases, pregnant and lactating women, individuals with a history of alcohol or drug abuse, those who have received intra-articular corticosteroids, and patients with coexisting autoimmune disorders. The test drug, Habb-e-Hindi, is a classical Unani formulation comprising Suranjan Sheeren (Colchicum luteum), Badang Babli (Ebelia ribes), Zanjabeel (Zingiber officinale), Muqil (Commiphora wightii), Asgandh (Withania somnifera), Bozidan (Tanacetum umbelliferum), Badhara (Stereospermum suaveolens), Musli Safed (Chlorophytum borivilianum), Sheetraj (Plumbago zeylanica), Mirch Siyah (Piper nigrum), Zeera Siyah (Cuminum cyminum), and Maweez Munaqqah (Vitis vinifera), all authenticated by a certified botanist before preparation. These ingredients are finely ground and processed into tablets, administered orally at a dosage of 2.5 g twice daily after meals with water, aimed at reducing joint inflammation, relieving pain, improving mobility, and restoring humoral balance. The control drug for comparison is Baricitinib 4 mg, administered once daily after meals, serving as an active comparator to assess the relative safety and efficacy of the Unani formulation. This structured approach allows a comprehensive evaluation of the therapeutic potential of Habb-e-Hindi in managing Waja-ul-Mafasil Murakkab (Rheumatoid Arthritis). |