| CTRI Number |
CTRI/2025/07/090517 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To observe the changes occurred in the body of women regarding menstrual cycle due to oral intake of ghee with increment in doses for three to seven days. |
|
Scientific Title of Study
|
Effect of Shodhanartha Snehapana on the physiology of menstrual cycle - an open labelled randomized placebo controlled comparative clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puja Nahak |
| Designation |
PhD 1st year |
| Affiliation |
ITRA, Jamnagar |
| Address |
Department of panchkarma, 4th floor, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India, 361008
Department of panchkarma, 4th floor, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India,361008
Jamnagar
GUJARAT
361008
India |
| Phone |
7978692185 |
| Fax |
|
| Email |
drpujanahak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
H.O.D., Department of Panchkarma |
| Affiliation |
ITRA, Jamnagar |
| Address |
Department of panchkarma, 4th floor, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India, 361008
Department of panchkarma, 4th floor, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India,361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
H.O.D., Department of Panchkarma |
| Affiliation |
ITRA, Jamnagar |
| Address |
Department of panchkarma, 4th floor, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India, 361008
Department of panchkarma, 4th floor, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India,361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda, opp. reliance mall, jamnagar |
| 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 |
| Dr Puja Nahak |
Institute of Teaching and Research in Ayurveda hospital, Jamnagar |
Room no. 425, department of Panchakarma, Institute of Teaching and Research in Ayurveda, opp to B- division police station, infront of reliance mall, jamnagar,361008
Jamnagar
GUJARAT |
7978692185
drpujanahak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of ITRA, jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: RUTUKALAH-RUTUMATIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Snehapana Karma | (Procedure Reference: , Procedure details: Ghee will be administered with an increase in doses for three to seven days.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Capsule filled with wheat flour (placebo) | Placebo will be given for 10 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women having regular menstrual cycle with an interval of 21-35 days.
Women within the age group of 14-40 years.
Women who are Yogya for Virechana Karma.
Women willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Women who have irregular menstrual cycle in terms of interval.
Women who have heavy bleeding during menstruation.
Women taking medications for any disorder related to thyroid, for depression or other psychiatric disorder.
Women diagnosed with uncontrolled diabetes mellitus, hypertension or any other chronic illness.
Women having any pelvic pathologies like fibroid uterus adenomyosis etc.
Women having BMI more than 30 Kg per m2.
Women who are taking or have implanted any contraceptives.
Pregnant and lactating women.
Ayogya for Virechana Karma.
Women unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shodhanartha Snehapana has some effect on physiology of menstrual cycle and hormones I e. FSH, LH and estradiol and it will enhance the follicular growth, ovulation and endometrial thickness |
Three to seven days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present clinical trial is an open labelled randomized placebo controlled comparative clinical trial on women having regular menstrual cycle. In this study total 100 patients will be registered and divided into two groups with minimum 50 patients in each group to assess the effect of Shodhanartha Snehapana on the physiology of menstrual cycle. In the intervention Group A will receive Snehapana with cow’s ghee for Shodhanartha Snehapana as a Purva Karma of Virechana Karma for 3-7 days and Group B will receive placebo for 10 days. |