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
|
|
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
|
|
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). |