| CTRI Number |
CTRI/2021/05/033660 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Gout (Pain in joints) with Unani medicines Majoon-e-Yahya Bin Khalid and Roghan-e-Naf-e-Warm-e-Niqras |
|
Scientific Title of Study
|
Clinical study on validation of Unani Pharmacopoeial formulation Majoon e Yahya Bin Khalid and Roghan e Naf e Niqras in Niqras (Gout) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/G/MY-RN/CLNVAL/CCRUM/19-20, Version 2 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room no. 502, Central Council for Research in Unani Medicine (CCRUM) Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room no. 507, Central Council for Research in Unani Medicine (CCRUM) Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room no. 516, Central Council for Research in Unani Medicine (CCRUM) Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Aligarh Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
| Type of Sponsor |
Research institution |
|
|
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 Rashid ul Islam |
Regional Research Institute of Unani Medicine, Aligarh |
Research OPD Room Niqras (Gout) Post Box No. 70, Shahjahan Manzil, Near AMU Riding Club, Qila Road
Aligarh
UTTAR PRADESH |
9897975161
waytorashid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M100||Idiopathic gout, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-e-Yahya Bin Khalid and Roghan-e-Naf-e-Warm-e-Niqras |
5gm orally twice daily to be taken with water and massage with 2ml oil locally twice daily for twelve weeks respectively |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either sex between the age groups of 18 years to 65 years.
2. Subjects fulfilling the 2015ACR/EULAR-criteria for diagnosis of gout(≥8)
|
|
| ExclusionCriteria |
| Details |
1. Acute Gouty arthritis
2. Subjects having any systemic illness requiring long term treatment
3. Pregnant and lactating women
4. Intolerant to therapy
5. Subjects who received any local injection in the previous 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Niqras (Gout) |
every 2 weeks for twelve weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
17/05/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single arm trial in patients with Niqras (Gout). After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulations Majoon-e-Yahya Bin Khalid and Roghan-e- Naf-e- Warm-e-Niqras. 5gm of Majoon-e-Yahya Bin Khalid shall be given orally twice a day and 2ml of Roghan-e- Naf-e- Warm-e-Niqras shall be applied locally twice a day. Both the formulations will be given for 12 weeks. The patients will be assessed clinically at every 2 weeks of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 12weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.(A) Composition of Majoon-e-Yahya Bin Khalid48 | S. No. | Ingredients | Botanical/Scientific Name | Quantity | | 1. | Asaroon | AsarumeuropeaumLinn. | 75 g. | | 2. | Zanjabeel | Zingiber officinaleRosc. | 75g. | | 3. | Zeera Siyah | CarumcarviLinn. | 75g. | | 4. | FilfilDaraz | Piper longumLinn. | 75g. | | 5. | Suranjan Shireen | Colchicum autumnale | 75g. | | 6. | Sana | Cassia Angustifolia Vahl. | 75g. | | 7. | QandSafaid | Refined sugar | 250g. | (B) Composition of Roghan-e-Warm-e-Naf-e-Niqras47 | S. No. | Ingredients | Botanical/Scientific Name | Quantity | | 1. | Babuna | Matricaria chamomilla Linn. | 100g. | | 2. | Anab-us-Salab | Solanum nigrum Linn. | 100g. | | 3. | Parsiaoshan | Adiantum capillus-veneris Linn. | 100g. | | 4. | Ikleel-ul-Malik | TrigonellaUncataBoiss. | 100g. | | 5. | Barg-e-Hina | Lawsoniainermis Linn. | 100g. | | 6. | Suranjan | Colchicum luteum Baker. | 100g. | | 7. | Buzidan | Orchis latifoliaLinn. | 100g. | | 8. | Mughas (MaidaLakri) | LitseachinensisLinn. | 100g. | | 9. | Gul-e-Khatami | Althaea officinalis Linn. | 100g. | | 10. | Gul-e-Babuna | MatricariachamonillaLinn. | 100g. | | 11. | Asl-us-Soos | Glycyrrhiza glabra Linn. | 100g. | | 12. | Irsa | Iris ensataThunb. | 80g. | | 13. | Aab | Water | 5 Lit | | 14. | Roghan-e-Kunjad | Sesamum indicum Linn. | Q.S | | 15. | Roghan-e-Zeet | Oil of Olea europaea L. | Q.S | | 16. | Roghan-e-Tukhm-e-Khashkhaash | Oil ofPapaver somniferum Linn. | Q.S | | 17. | Roghan-e-Tukhm-e-Kharpaza | Oil ofCucumismelo Linn. | Q.S | |