FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/10/005081 [Registered on: 08/10/2014] Trial Registered Prospectively
Last Modified On: 10/10/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Role of certain Ayurvedic Drugs in the Management of Piles. 
Scientific Title of Study   A Clinical Evaluation of Triphala Guggulu and Kasisadi Taila in the management of Arsha (Haemorrhoids).  
Trial Acronym  CETKMA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prem Lal Bharati 
Designation  Research Officer-Ay (S-2) 
Affiliation  National Research Institute for Ayurveda-Siddha Human Resource Development 
Address  National Research Institute for Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior (M.P.)
Aamkho, Gwalior (Madhya Pradesh)
Gwalior
MADHYA PRADESH
474009
India 
Phone  9407587686  
Fax  07512430317  
Email  plbharati@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prem Lal Bharati 
Designation  Research Officer-Ay (S-2) 
Affiliation  National Research Institute for Ayurveda-Siddha Human Resource Development 
Address  National Research Institute for Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior (M.P.)
Aamkho, Gwalior (Madhya Pradesh)

MADHYA PRADESH
474009
India 
Phone  9407587686  
Fax  07512430317  
Email  plbharati@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prem Lal Bharati 
Designation  Research Officer-Ay (S-2) 
Affiliation  National Research Institute for Ayurveda-Siddha Human Resource Development 
Address  National Research Institute for Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior (M.P.)
Aamkho, Gwalior (Madhya Pradesh)

MADHYA PRADESH
474009
India 
Phone  9407587686  
Fax  07512430317  
Email  plbharati@rediffmail.com  
 
Source of Monetary or Material Support  
National Research Institute for Ayurveda Drug Development, Kolkata (W.B.) 
National Research Institute for Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior (M.P.)  
National Veterinary-Ayurveda Research Institute & Hospital, Lucknow (U.P.) 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite ‘D’ Block, Janakpuri, New Delhi- 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr L D Barik  National Research Institute for Ayurveda Drug Development,   4 CN Block, Sector V, Bidhan Nagar, Kolkata (West Bengal)
Kolkata
WEST BENGAL 
9433110117
03323671001
ldbarik1963@yahoo.co.in 
Dr Prem Lal Bharati  National Research Institute for Ayurveda-Siddha Human Resource Development  Aamkho, Gwalior (Madhya Pradesh)
Gwalior
MADHYA PRADESH 
9407587686
07512430317
plbharati@rediffmail.com 
Dr S K Singh  National Veterinary-Ayurveda Research Institute & Hospital  474/6, Sitapur Road, Lucknow (Uttar Pradesh)
Lucknow
UTTAR PRADESH 
8090697279
05222743213
drsksingh2005@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethical Committee of National Research Institute for Ayurveda Drug Development, Kolkata (W.B.)  Approved 
Institutional Ethical Committee of National Research Institute for Ayurveda-Siddha Human Resource Development, Aamkho, Gwalior (M.P.)  Approved 
Institutional Ethical Committee of National Veterinary-Ayurveda Research Institute & Hospital, Lucknow (U.P.)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Haemorrhoids (Arsha),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Triphala Guggulu {AFI, Part-I, 5:5 (Sarangdhara Samhita Madhyamakhanda Adhyaya 7: 82-83)} and Kasisadi Taila (AFI, Part-I, Vol-I, 8: 7 Page-131)  1.Triphala Guggulu {AFI, Part-I, 5:5 (Sarangdhara Samhita Madhyamakhanda Adhyaya 7: 82-83)} Dose:1gm twice daily Dosage form :Tablet of 500 mg Route of Administration: Oral Time of Administration: Twice a day before food Anupana Lukewarm Water Packing form Container containing of 28 tablets for a week (4 such containers for 4 weeks) Duration of therapy: 4 weeks and 2.Kasisadi Taila (AFI, Part-I, Vol-I, 8: 7 Page-131) Dose:10 ml twice a day Dosage form :Liquid Route of Administration :Local Time of Administration :Twice a day Anupana :- Packing form :Plastic Container of 140 ml for a week (4 such containers for 4 weeks) Duration of therapy: 04 weeks Follow up period : 02 weeks without medication  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either sex aged 16 –60 years.
2.Presence of 1st, 2nd & 3rd degree Arsha (Hemorrhoids) confirmed by clinical / proctoscopic / colonoscopic examination (With or without bleeding / painful or painless).
3.Willing and able to participate in the study for 06 weeks
 
 
ExclusionCriteria 
Details  1.Age below 15 years & above 60 years
2.Thrombosed & Strangulated pile mass (Hemorrhoids)
3.Bleeding diathesis
4.Cirrhosis of Liver- Portal hypertension
5.Ulcerative colitis / Crohn’s disease
6.Patients with evidence of malignancy
7.Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immunosuppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
8.Patients suffering from major systemic illness necessitating long term drug etc.
9.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
10.Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
11.Symptomatic patient with clinical evidence of Heart failure.
12.Patients having uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250mg/dl).
13.Patients with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 2 times upper normal limit) or renal disorders (defined as S.creatinine >1.2mg/dL), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel
14.Disease or any other condition that may jeopardize the study..
15.Pregnant/ lactating females.
16. Patients on oral contraceptives.
17.Alcoholics and/or drug abusers.
18.H/o hypersensitivity to any of the trial drugs or their ingredients.
19.Patients who have completed participation in any other clinical trial during the past six (06) months.
20.Any other condition which the Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the Pile Mass evident by Inspection / Proctoscopy (Visual perception by physician and Photography)  2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
1.Control of Bleeding as assessed by physician.
2.Relief from Constipation (subjective through interrogation)
3.Improvement in Quality of Life as assessed by SF-36 
2 Years 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)
Modification(s)  
01/12/2014 
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   The trial result would be published by the Council after the statistical analysis at the end of clinical trial. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction:

Hemorrhoids (Arsha) disease is the commonest problem which is seen in the anal region due to hereditary, anatomical deformities, physiological causes, diet, secondary to disease, pregnancy etc.. A large database survey conducted in the United States and England found a prevalence of approximately 4 percent.  The prevalence was equal in both sexes, peaking between the ages of 45 and 65, and declining thereafter. Development of symptoms prior to age 20 was unusual.The main cause of haemorrhoids is constipation. Constipation over a prolonged period of time, and have to strain to pass stools, it can damage the lining of anal canal. The increased pressure in the blood vessels of anus causes them to swell, resulting in the formation of haemorrhoids. Overweight and lot of heavy lifting are more prone to haemorrhoids.

            Common symptoms of haemorrhoids include Itching around the anus, Bleeding from the anus after going to the toilet, Discomfort or ache around the anus and lower bowel (rectum), Pain during and immediately after a bowel motion, Visible swelling around the anus, feeling that bowels have not been completely emptied etc. Haemorrhoids vary in size, and can occur internally (inside) or externally (outside) the anus. Internal haemorrhoids develop in the back passage, about 2- 4cm above the opening of the anus. External haemorrhoids are less common, and develop on the outside edge of the anus.

Modern system of treatment has adopted a variety of methods like sclerotherapy (injection of sclerosent agent in submucous spaces of piles), rubber band ligation, infra red coagulation (IRC), cryosurgery (using N2O gas), hemorrhoidectomy etc., according to the nature and degree of pile mass, but these procedures have their own merits and demerits with limitations.

The ancient acharyas have described this disorder as one of the mahagada and as a surgical domain. This disease is largely confined to the Guda but also in Nasa, Netra, Karna, Twacha, etc. regions. Etiological factors are vitiation of doshas in Guda valis, injury due to thorn, stone, nail, riding on horse, vehicles, sitting on irregular surfaces, regular contact of cold water etc., Charaka has given more emphasis on the conservative treatment and prescribed suitable dietary regimes with drugs to the patients for curing of Arsha by improving deepan and pachan karmas of the agni (enhancement of digestive capacity) in the body. Further, he has also advised kshara treatment for different types of Arsha. However, every system of medicine has given its own way of treatment for treating the Arsha.

Sushruta has described fourfold method of treatments of Arsha (Su. Ci. 6), which are Bheshaja, Kshara, Agni and Shastra. Bheshaja i.e.Medical/conservative treatment includes various Ayurvedic medicines which decrease intra abdominal pressure, act as mild laxatives and thus give relief in the particular situation. Some other Oils/like Kasisadi taila when used locally (Lekhana) imparts relief in Arsha. The commonly used medicines are – Abhayarishta, Draksharishta, Satsakara churna, Triphala churna, Satpushpadi churna etc. Locally Kasisadi taila and inflammatory conditions Jatyadi taila are prescribed

In certain other cases Ksarakarma and Ksharasutra are used effectively. Plain thread ligation of prolapsible internal haemorrhoids is also a popular method of treating the haemorrhoids on OPD basis (Sharma, 1999). Raktavasecana, Agnikarma and Shastrakarma are some other methods. However the Shastrakarma needs general/spinal anaesthesia. Bheshaja (Medicine) treatment is the most suitable treatment in the Arsha because of It is safe and easily available method to prescribe medicines and patient’s acceptability is good. Bheshaja chikitsa can however be mixed with other techniques or therapeutic measures.

Ayurvedic medicines Triphala Guggulu is described in the Sharangdhar Samhita (Madhyamakhanda adhyaya 7/82-83) and Kasisadi tail in Bhaisajyaratnavali (Arshorogadhikar 111-113) for the treatment of Arsha (Haemorrhoid). In the present study 50 patients will be studied in this IMR project. The observations and discussion will be made according to statistical analysis on different standard parameters and SF-36-Health Survey Score. The aim of this study is to evaluate of clinical efficacy of Triphala Guggulu and Kasisadi Taila in the Management of Arsha (Haemorrhoids).

Composition of Triphala Guggulu: (Sharangdhar samhita Madhyakhanda 7/82-83)

1.Haritaki, 2.Bibhitaki, 3. Aamalaki, 4. Pippali, and 5. Suddha Guggulu 

Composition of Kasisadi Taila : (Bhaisajyaratnavali Arsorogadhikar 111-112)

1. Kasisa, 2. Saindhav lavana, 3. Pippali, 4. Sunthi, 5. Kustha, 6. Langali, 7. Pasanbheda, 8. Karavira, 9. Danti, 10. Vidanga, 11. Citraka, 12. Haritala, 13. Manahsila, 14. Swarnaksiri, 15. Snuhi, 16. Arkapayas, 17. Tila taila  and 18. Go Mutra.

 
Close