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CTRI Number  CTRI/2018/05/013978 [Registered on: 21/05/2018] Trial Registered Retrospectively
Last Modified On: 14/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Effect of Emesis Unani formulation and massage therapy in Knee pain 
Scientific Title of Study   Efficacy of Qai Munzij wa Mushile Balgham and Dalk with Roghane Chobchini in Waja ur Rukba (Knee Osteoarthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sayyed Adnan Mohammad 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  OPD no 28. National Institute of Unani Medicine. Kottigepalya. Magadi main road. Bengaluru.

Bangalore
KARNATAKA
560091
India 
Phone  8123068551  
Fax    
Email  sayyed224@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abdul Nasir Ansari 
Designation  Reader and HoD. Dept. of Ilaj Bit Tadbeer. 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine. Kottigepalya. Magadi Main Road. Bengaluru.

Bangalore
KARNATAKA
560091
India 
Phone  9379165162  
Fax    
Email  abdulnasiransari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abdul Nasir Ansari 
Designation  Reader and HoD. Dept. of Ilaj Bit Tadbeer. 
Affiliation  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine. Kottigepalya. Magadi Main Road. Bengaluru.

Bangalore
KARNATAKA
560091
India 
Phone  9379165162  
Fax    
Email  abdulnasiransari@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  OPD no 28. Dept of Ilaj Bit Tadbeer. National Institute of Unani Medicine. Kottigepalya. Magadi Main Road. Bengaluru. 91 
Type of Sponsor  Research institution and hospital 
 
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 
Sayyed Adnan Mohammad  National Institute of Unani Medicine  OPD no 28. National Institute of Unani Medicine. Kottigepalya. Magadi Main Road. Bengaluru
Bangalore
KARNATAKA 
8123068551

sayyed224@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NIUM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients having knee pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Decoction for Qai, Decoction for Munzij, Decoction for Mushil and Roghane Chobchini for Dalk  Decoction for Qai:(once only) Tukhme Shibt (Anethum graveolens) 3gm, Aslussoos (Glycyrrhiza glabra) 5gm boiled in water mixed with honey(25gm). Decoction was given orally on 1st day. Decoction for Munzij: Aslussoos (Glycyrrhiza glabra) 5gm Tukhm-e-kasni (Cichorium intybus) 7gm Maveez Munaqqa (Vitis vinifera) 9no. Tukhm-e-Kharpaza (Cucumis melo) 7gm Tukhm-e-Khatmi (Althaea officinalis) 5gm Suranjan shireen (Colchicum autumnale) 3gm Boozidan (Tanacetum umbelliferum)5gm Anisoon (Pimpinella anisum) 3gm Badranjboya (Melissa officinalis) 5gm Parsiyaoshan (Adiantum capillus-veneris) 5gm Favvah (Rubia cordifolia) 3gm All the above drugs were kept in water overnight and given in morning on empty stomach orally from 2nd to 15th day of treatment. Decoction for Mushile balgham: Barg-e-Sana (Cassia angustifolia)5gm Turbud (Ipomoea turpethum) 5gm Zanjabeel (Zingiber officinale) 1gm Barang Kabli (Embelia ribes) 2gm Maghz Khayar Shambar (Cassia fistula) 25gm All the above contents are mixed with contents of Munzij balgham and administered orally on 13th and 15th day of treatment. Roghan-e-Chobchini: Chobchini (Smilax china) 8gm Barge mehndi (Lawsonia inermis) 40gm Suranjan Shireen (Colchicum autumnale) 40gm Rasaut (Berberis aristata) 40gm Roghan-e-Kunjad (Oil of seeds of Sesamum indicum) 2.4 litre. An oil was prepared from above drugs and 25 ml oil was applied locally on affected knee/s. for 10 minutes daily from 16th to 30th day. Summary: 1st day: Decoction for Qai 2nd to 15th day: Decoction for Munzij balgham 13th and 15th day: Mushile balgham alongwith Munzij balgham. 16th to 30th day: Massage with Roghan-e-Chobchini. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
1.Both genders.
2.Age group 40 to 60 years.
3. ACR criteria (Clinical and Radiographic criteria)
i. Knee pain for most days of prior month
ii. Osteophytes at joint margins
iii. Synovial fluid typical of osteoarthritis
iv. Age ≥ 40 years
v. Morning stiffness lasting ≤ 30 min
vi. Crepitus with active joint motion
Diagnosis requires: i+ii, or i+iii+v+vi, or i+iv+v+vi
 
 
ExclusionCriteria 
Details  Exclusion criteria :

1. Pregnancy and lactation
2.Patients with systemic and metabolic diseases
3.Patients of knee joint pathology other than osteoarthritis
4.Patients with the history of trauma and accidents involving knee joints
5.Known cases of gastric ulcer and esophageal varices
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain subscale of KOOS  baseline, 15th day and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of above mentioned regimes on symptoms, activities of daily living, sports and quality of life in knee osteoarthritis.  baseline, 15th day and 30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/07/2017 
Date of Study Completion (India) 05/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Osteoarthritis (Waja-ul-Mafasil) is a chronic disorder of synovial joints in which there is progressive softening and disintegration of articular cartilage accompanied by new growth of cartilage and bone at the joint margins, cyst formation and sclerosis in the subchondral bone, mild synovitis and capsular fibrosis. Osteoarthritis is the commonest of all joint diseases and the knee is the commonest of the large joints affected by osteoarthritis. Indians have increased knee osteoarthritis as compared to western people. The reported prevalence of osteoarthritis in rural India is 5.8%. According to World Health Organization (WHO), Osteoarthritis is second commonest musculoskeletal problem in the world population (30%) after back pain (50%). Ninety percent of all people have radiographic features of osteoarthritis in weight bearing joints by age 40. The main presenting symptoms of osteoarthritis are pain and functional restriction..

 

The current treatment of osteoarthritis is aimed at minimising pain, optimizing function and reducing disability using a combination of non pharmacological, pharmacological and surgical therapies. Non pharmacological therapies include patient education and joint protection measures. Pharmacological management includes Non-steroidal anti-inflammatory drugs (NSAIDs) which are used to treat pain and inflammation in OA. Their use is limited by their gastric and renal toxicity, especially in the elderly. Intra-articular steroids are employed in patients with knee OA who have effusion. Repeated steroid injections may lead to more cartilage damage. Surgical management includes joint replacement in end stage joint disease. Other surgical therapies available are with varying grades of efficacies.

 

Thus, no curative therapy exists for osteoarthritis. In view of high prevalence, obnoxious side effects of pharmacological treatment and high cost of surgical interventions with less effectiveness of all treatment modalities, there is need for search of safe, economic and effective treatment in Unani system of Medicine for osteoarthritis, particularly of a knee joint. Various treatments are described in Unani Literature for Waja-ul-Mafasil. Hakim Muhammad Azam Khan mentioned Qai, Munzij wa Mus’hil-e-Balgham in management of Waja-ul-Mafasil. Further he mentioned Dalk with Roghan-e-Chobchini.

This open, pre and post clinical study was started after ethical clearance from IEC. Patients fulfilling inclusion criteria were enrolled in the study from OPD and IPD of NIUM Bengaluru after obtaining written informed consent. 30 patients completed the trial. Qai was induced on the 1st day of treatment by Joshanda of Tukhm-e-Shibt and Aslussoos mixed with honey. From 2nd day, Joshanda Munzij-e-Balgham (containing Aslussoos, Tukhm-e-Kasni, Maweez Munaqqa, Tukhm-e-Kharpaza, Tukhm-e- Khatmi, Suranjan Shireen, Boozidan, Anisoon, Badranjboya, Parsiyaoshan, Favvah) was administered till 15th day of treatment. Joshanda Mus’hil-e-Balgham, containing Barg-e-Sana, Turbud, Zanjabeel, Barang Kabli, Maghz Khayar Shambar, was given on 13th and 15th day along with Joshanda Munzij-e-Balgham. From 16th day onwards, Dalke Layyin Kaseer was started with Roghan-e-Chobchini till 30th day. Patients were assessed at baseline, 15th day and 30th day using objective parameters KOOS and VAS. Safety parameters were assessed before and after the study. The Statistical software namely SPSS 18.0, and R environment ver.3.2.2 were used for the analysis of the data. Student t test (two tailed, dependent) has been used to find the significance of study parameters as well as safety parameters.

It was observed that VAS score was reduced significantly after treatment. VAS score in right knee was reduced from 6.86±1.48 to 3.45±1.40. Result was found statistically significant (p < 0.001). VAS score in left knee reduced from 6.79±1.50 at baseline to 3.17±1.10 after treatment. The mean difference was highly significant (p<0.001)

Assessment of symptoms, pain, ADL, sports/recreation and Quality of life was done by using KOOS which showed significant improvement. Symptoms improved significantly from 44.38±17.86 to 69.07±12.36 in the right knee and from 46.66±16.65 to 71.00±11.07 in the left knee after the treatment. Pain in the right knee improved from 37.83±18.09 to 66.83±13.56 and in the left knee it showed significant improvement from 38.79±19.25 to 67.76±14.20. ADL improved significantly from 41.00±17.06 to 64.31±16.20 in right knee and also improved significantly from 41.31±17.07 to 66.00±14.48 in left knee. Sports/recreation subscale score improved significantly from 32.24±16.93 to 63.28±11.28 in right knee and from 33.28±18.63 to 63.45±12.33 in the left knee, which was strongly significant statistically. Quality of life score improved significantly from 24.93±13.68 to 59.30±12.94. 

Properties of various ingredients of the test formulation strongly suggest the potential to treat the sign and symptoms of Waja-ur-Rukba and, therefore, validated their efficacy in this trial. The study involving Qai, Munzij wa Mus’hil-e-Balgham and Dalk with Roghan-e-Chobchini was found effective in treating Waja-ur-Rukba (knee osteoarthritis). 

 
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