CTRI/2024/12/078715Not yet recruitingNot Applicable
Pharmaceutico-analytical study and clinical evaluation of Tiktadi Ghrita Ointment in Kikkisa with special reference to Striae gravidarum: A Randomized Controlled Trial
Dr Alka Gajanan Khade1 site in 1 country64 target enrollmentStarted: January 10, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Pharmaceutico-analytical Studies of Tiktadi Ghrita Ointment
Study Overview
Brief Summary
In the present study, total 64 participants will be taken for trial dividing them in 2 equal groups.
Grp-A will receive the trial drug ’Tiktadi Ghrita Ointment’and Grp-B will receive the controlled drug ’Karveer Taila’
for external application for 45 days. Follow up will be taken on Day-15,30,45. Result will be
concluded based on assessment criteria.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patients willingly participating in the trial and giving consent form.
- •â€¢ Selection of patient will be Primigravida only.
- •â€¢ Women diagnosed with symptoms of Kikkisa –
- •Vaivarnya (Discoloration)
- •Kandu (Itching)
- •Vidah(Burning sensation)
- •Rekha Swarupa Twak Sankocha (Linear line marking and contractions of the skin in the abdomen).
Exclusion Criteria
- •1.Women suffering from any other skin diseases except Kikkisa.
- •2.Known case of any systemic illness like tuberculosis,HIV, Hepatitis B, Hepatitis C, Diabetes mellitus, Hyperbilirubinemia,etc 3.Presence of any surgical scar on the abdomen.
- •4.High-risk pregnancy.
- •(multiple pregnancy, pregnancy induced hypertension, Polyhydramnios, etc.).
Outcomes
Primary Outcomes
Pharmaceutico-analytical Studies of Tiktadi Ghrita Ointment
Time Frame: 6 Months
Secondary Outcomes
- This study may prove Tiktadi Ghrita Ointment as effective treatment in the management of Kikkisa(Follow up on 15th,30th & 45th Day)
Investigators
Dr Alka Gajanan Khade
Shri Ayurveda Mahavidyalaya, Nagpur
Study Sites (1)
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