| CTRI Number |
CTRI/2018/04/013398 [Registered on: 20/04/2018] Trial Registered Prospectively |
| Last Modified On: |
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| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Nano Haritaki and Haritaki Choorna in Constipation. |
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Scientific Title of Study
|
An Open Labeled, Active Controlled, Randomized, Parallel Group Study Of Efficacy Of Nano Haritaki In Malavshtambha Vis-À-Vis Functional Constipation |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Assistant Professor, department of Kayachikitsa, Sumatibhai Shah Ayurved Mahavidyalaya. |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9096082950 |
| Fax |
02026999467 |
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Assistant Professor, department of Kayachikitsa, Sumatibhai Shah Ayurved Mahavidyalaya. |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9096082950 |
| Fax |
02026999467 |
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Vijay Jagtap |
| Designation |
PG Scholar (Kayachikitsa) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi,
Hadapsar, Pune
Sai Classic, flat No.7 Satavwadi, Hadapsar, Pune 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9607265310 |
| Fax |
|
| Email |
nehavjagtap44@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Maharashtra Arogya Mandals Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Malwadi, Hadapsar, Pune - 411028 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali Deshpande |
Maharashtra Arogya Mandals Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
OPD No.1 & 2 Department of Kayachikitsa
Pune
MAHARASHTRA |
9096082950
dr.vaishalid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maharashtra Aarogya Mandal’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi , Hadapsar, Pune-28 |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Functional constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Haritaki Choorna |
5gm dose at bed time for 14 days |
| Intervention |
Nano Haritaki |
1gm dose at bed time for 14 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having complaint Malavshtambha vis-a-vis functional constipation
2) Patient ready for the study and willing for treatment
3) Patient fulfilling Rome III criteria with symptoms
Criteria fulfilled for the last 3 months with symptom onset at least 6 month prior to diagnosis.
|
|
| ExclusionCriteria |
| Details |
1) Pregnant and lactating women.
2) K/C/O uncontrolled Diabetes Mellitus, uncontrolled thyroid disorder, Renal failure, Anorectal disorders
3) Medication induced constipation eg. Iron suppliments etc.
|
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1) To study the efficacy of Nano Haritaki in constipation by constipation assessment scale.
2) To study the efficacy of Haritaki in constipation by constipation assessment scale.
3) To compare the efficacy of Nano Haritaki and Haritaki in constipation by constipation assessment scale. |
1)at baseline, 7th day & 14th day.
2)at baseline, 7th day & 14th day.
3)at baseline, 7th day & 14th day. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the effect of Nano Haritaki in constipation by assessing Quality of Life – patients of constipation questionnaire.
2)To study the effect of Haritaki in constipation by assessing Quality of Life – patients of constipation questionnaire.
3)To compare the efficacy of Nano Haritaki and Haritaki in constipation by assessing Quality of Life – patients of constipation questionnaire.
|
1)at baseline, 7th day, 14th day
2)at baseline, 7th day, 14th day
3)at baseline, 7th day, 14th day |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
01/06/2018 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Functional constipation is a common gastrointestinal symptom with which patients are presented in clinics. A Rome III diagnostic criteria defines functional constipation as ‘A group of functional disorders which present as persistant difficult, infrequent, or incomplete defeacation. Available therapeutic options include stool softners, fibre suppliments, osmotic and stimulant laxatives. Prolonged use of laxatives may cause bloating, painful abdominal cramps, dehydration, diarrhoea, intestinal obstruction. Also various Rechak, Anulomak drugs are described in Ayurveda like Haritaki (Terminalia chebula), Amlaki (Phyllanthus emblica), Manuka (Vitis vinifera), Falsa (Grewia asiatica) , Aragvadha (Cassia fistula). These drugs have Katu, Tikta Kashaya Rasa (pungent, bitter, astringent tastes) which can cause unpleasantness, nausea, cardiac discomfort etc. Nano Technology is an applied branch of basic science where particle size of drug is reduced to Nanometric scale (10-9). This increases bio-availability of drug, increases palatability and reduces exploitation of plants. Thus it is decided to study of efficacy of ayurvedic drug based on Nano Technology in functional constipation. Diagnostic Criteria It has been observed by various researchers that the prevalence of constipation differs when different criteria are used. Hence to bring uniformity in clinical trials and epidemiological studies across the world Rome criteria are used. Rome III functional constipation Diagnostic criteria 1. Must include two or more of the following: a. Straining during at least 25% of defecations b. Lumpy or hard stools in at least 25% of defecations c. Sensation of incomplete evacuation for at least 25% of defecations d. Sensation of anorectal obstruction/blockage for at least 25% of defecations e. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor) f. Fewer than three defecations per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome CRITERIA FOR ASSESSMENT OF EFFICACY:- 1. Constipation Assessment Scale - at Baseline, 7th day and 14th day 2. Quality of Life- patients of constipation - at Baseline, 7th day and 14th day
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