| CTRI Number |
CTRI/2018/02/011980 [Registered on: 19/02/2018] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Soup and cookies made from Ayurvedic herbs for treatment of painful and irregular menstruation |
|
Scientific Title of Study
|
Designing and Therapeutic assessment of the nutritional cum restorative formulation for painful-irregular menstruation in young and adolescent girls of Gujarat |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jasmine Gujarathi |
| Designation |
Professor & Head |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research |
| Address |
404 Siddhi Darshan Flats
Opp Bansi Vihar
Anand Vidyanagar Road
Anand
New Vallabh Vidyanagar
Anand
Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9408365891 |
| Fax |
02692235051 |
| Email |
jassyleo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Jani |
| Designation |
Professor & Head |
| Affiliation |
Shree Rasiklal Manikchandji Dhariwal Ayurveda College And Hospital |
| Address |
Kesarsuri Jnanavihara Sankul,
N H no 8,
Wagaldhara Road,
Valsad Dist
Wagaldhara Road
Valsad District
Valsad
GUJARAT
396375
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine Gujarathi |
| Designation |
Professor & Head |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research |
| Address |
404 Siddhi Darshan Flats
Opp Bansi Vihar
Anand Vidyanagar Road
Anand
New Vallabh Vidyanagar
Anand
Gujarat
Anand
GUJARAT
388001
India |
| Phone |
9408365891 |
| Fax |
02692235051 |
| Email |
jassyleo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gujarat Council of Science and Technology
Block B 7th Floor MS Building
Near Pathikashram
Sector 11
Gandhinagar
Gujarat 382011 |
|
|
Primary Sponsor
|
| Name |
GUJCOST |
| Address |
Department of Science and Technology, Government of Gujarat
Block B, 7th Floor MS Building Sector 11 Gandhinagar, Gujarat 382011 |
| Type of Sponsor |
Government funding agency |
|
|
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 Jasmine Gujarathi |
Department of Prasuti tantra and Stri roga OPD No 27 |
G J Patel Institute of Ayurvedic Studies and Research
New Vallabh Vidyanagar
Anand
Anand
GUJARAT |
9408365891
02692235051
jassyleo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, Young and adolescent girls with dysmenorrhoea and irregular menstruation , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cookies formulation |
Cookies with base material of wheat flour with same ingredients as soup |
| Comparator Agent |
Rajapravartini vati |
Rajapravartini a classical formulation for painful menstruation as control group |
| Intervention |
Soup Formulation |
Soup prepared with base materials and herbs like Sunthi, Jeeraka, Krishna Jeeraka, Pippali, Ajmoda, Hingu, kanyasara, Garjara beeja,, Moolaka beeja and coriander seeds |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Female |
| Details |
After Menarche |
|
| ExclusionCriteria |
| Details |
Excessive menstruation
fibroid |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Nutritional cum curative Product for painful menstruation to the young females |
Aug 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| New Restorative and nutritional formulation |
3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="118" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2018 |
| Date of Study Completion (India) |
02/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Dilip Jani, Jasmine Gujarathi. Role of Zingiber officinale R. in dysmenorrhoea: a selective Ayurvedic and contemporary medicine documentation. J Pharm Sci Innov. 2016;5(5):160-167
2. Dilip Jani, Jasmine Gujarathi. Pharmacological Appraisal of Cuminum Cyminum L. In Dysmenorrhoea: An Ayurvedic Approach in Consideration of Current Evidences. International Journal of Ayurveda and Pharma Research. 2016;4(12):29-35.
3. Heavy Metal Analysis Of Raw Kaseesa By Inductively Coupled Plasma (ICP) under Publication. Authors – Dilip Jani, Jasmine Gujarathi, Praveen Ganorkar, K. Rukmini, Marian Patel, Harsha Jani, Mitesh Patel
4. Randomized Open Labelled Clinical Trial of Herbal cookies and Herbal soup on Dysmenorrhoea – A GUJCOST sponsored Minor Research Project IAMJ print version nov 2020 vol 5(1) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Statistical analysis of all three groups was highly significant on menstrual irregularity as well as dysmenorrhoea in terms of severity and duration. (P<0.001) In associated symptoms cookies showed highly significant change in scanty menstruation, constipation, diarrhea, fatigue, anorexia, headache, abdominal and giddiness. (P<=0.001) Soup showed statistically highly significant change in scanty menstruation, diarrhea, fatigue, anorexia, headache, abdominal pain and giddiness. In Rajapravartini group statistically highly significant result was obtained in scanty menstruation, fatigue, anorexia, headache, pain and giddiness. Percentage relief was 84.9% in pain in cookies group, 63.64% in soup group and 45.83% in rajapravartini vati group.Total effect of therapy on menstrual irregularity showed complete remission of symptoms in 66.67% girls of cookies group, 42.30% girls in soup group and 20% girls of rajapravartini vati group. Marked improvement in symptoms was seen in 25% girls of cookies group, 23.07% girls of soup group and 12.5% (3) girls of rajapravartini vati group. 25% (6)girls of Rajapravartini vati and 11.53% (3) girls of soup group remained unchanged. 19 girls (51.35%) showed complete relief in dysmenorrhoea in cookies group, 15 girls (40.54%) were completely treated in soup group and 6 girls (16.21%) found complete relief in dysmenorrhoea in rajapravartini vati group. Marked improvement in painful menstruation was found in 15 (40.54%) in cookies group, 12 (32.43%) in soup group and in 6 girls (17.14%) in rajapravartini group. 6 girls remained unchanged in rajapravartini vati group. In Haematological parameters all the groups showed similar change but cookies group showed statistically significant improvement in serum calcium levels. Total effect of therapy on menstrual irregularity showed complete remission of symptoms in 66.67% girls of cookies group, 42.30% girls in soup group and 20% girls of rajapravartini vati group. Marked improvement in symptoms was seen in 25% girls of cookies group, 23.07% girls of soup group and 12.5% (3) girls of rajapravartini vati group. 25% (6)girls of Rajapravartini vati and 11.53% (3) girls of soup group remained unchanged. 19 girls (51.35%) showed complete relief in dysmenorrhoea in cookies group, 15 girls (40.54%) were completely treated in soup group and 6 girls (16.21%) found complete relief in dysmenorrhoea in rajapravartini vati group. Marked improvement in painful menstruation was found in 15 (40.54%) in cookies group, 12 (32.43%) in soup group and in 6 girls (17.14%) in rajapravartini group. 6 girls remained unchanged in rajapravartini vati group. In Haematological parameters all the groups showed similar change but cookies group showed statistically significant improvement in serum calcium levels. |